← ALL REGULATORY CHANGES
FDA Regulatory Changes — 2024 archive
Every record published in 2024 — 748 in total. Follow any entry for the decoded detail page.
December 2024
- Flamingo Pharmaceuticals Ltd.; Withdrawal of Approval of Two Abbreviated New Drug Applications
- Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory Committee; Renewal
- Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products; Reopening of the Comment Period
- Uniform Compliance Date for Food Labeling Regulations
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; De Novo Classification Process (Evaluation of Automatic Class III Designation)
- Determination of Regulatory Review Period for Purposes of Patent Extension; NEXOBRID
- Determination of Regulatory Review Period for Purposes of Patent Extension; XTAMPZA ER
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Shortages Data Collection
- E11A Pediatric Extrapolation; International Council for Harmonisation; Guidance for Industry; Availability
- M15 General Principles for Model-Informed Drug Development; International Council for Harmonisation; Draft Guidance for Industry; Availability
- General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of Public Docket; Request for Comments-Dermal Fillers
- Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Draft Guidance for Industry; Availability
- Determination of Regulatory Review Period for Purposes of Patent Extension; OMISIRGE
- Transfer of Regulatory Responsibility From the Center for Devices and Radiological Health to the Center for Biologics Evaluation and Research; Medical Maggots and Medicinal Leeches
- Determination of Regulatory Review Period for Purposes of Patent Extension; VEOZAH
- Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
- Request for Nominations of Individuals and Industry Organizations for the Patient Engagement Advisory Committee
- E6(R3) Good Clinical Practice: Annex 2; International Council for Harmonisation; Draft Guidance for Industry; Availability
- Determination of Regulatory Review Period for Purposes of Patent Extension; ROCTAVIAN
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; National Agriculture and Food Defense Strategy Survey
- Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing Document; Draft Guidance for Industry; Availability
- Fosun Pharma USA Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction
- Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug and Veterinary Master Files
- Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Supplemental New Drug Application 218276 S-004 for FABHALTA (iptacopan) Oral Capsules in the Treatment of Adults With C3G
- Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”
- Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products
- Modifications to Labeling of Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependence
- Nonprescription Drug Product With an Additional Condition for Nonprescription Use
- Statement of Organization, Functions, and Delegations of Authority
- Monterey Mushrooms, LLC; Filing of Food Additive Petition
- Privacy Act of 1974; System of Records
- Export Lists for Human Food: Request for Information; Extension of Comment Period
- Statement of Organization, Functions, and Delegations of Authority
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution and Related Collections of Information
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request Data To Support Social and Behavioral Research as Used by the Food and Drug Administration
- Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additives Intended for Use in Animal Food, Food Additive Petitions, Investigational Food Additive Files Exemptions, and Declaration on Animal Food Labels
- Agency Information Collection Activities; Proposed Collection; Comment Request; Interstate Shellfish Dealer's Certificate and Participation in the National Shellfish Sanitation Program
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Laboratory Accreditation for Analyses of Foods
- Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling: Notification Procedures for Statements on Dietary Supplements
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Advanced Manufacturing Technologies Designation Program
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices
- Fiscal Year 2025 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments
- Determination of Regulatory Review Period for Purposes of Patent Extension; SOHONOS
- Determination of Regulatory Review Period for Purposes of Patent Extension; BYLVAY
- Advisory Committee; Science Board to the Food and Drug Administration; Renewal
- Registration and Listing of Cosmetic Product Facilities and Products; Guidance for Industry; Availability
- Revocation of Authorization of Emergency Use of B. Braun Medical's Perfusor Space Syringe Infusion Pump System, Infusomat Space Volumetric Infusion Pump System, and Outlook ES; Availability
- Leprino Nutrition; Filing of Food Additive Petition
- Standardized Format for Electronic Submission of Marketing Application Content for the Planning of Bioresearch Monitoring Inspections for Center for Drug Evaluation and Research Submissions; Guidance for Industry; Availability
- Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Extended-Release/Long-Acting Opioid Analgesic Postmarketing Requirement
- Expedited Program for Serious Conditions-Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Availability
- Determination That Bentyl Preservative Free (Dicyclomine Hydrochloride) Injection, 10 Milligrams/Milliliters, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Yong Sheng Jiao; Denial of Hearing; Final Debarment Order
- Food Date Labeling
- Notifying the Food and Drug Administration of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
- Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions; Guidance for Industry and Food and Drug Administration Staff; Availability
- Evaluating Target Animal Safety and Effectiveness of Antibacterial New Animal Drugs for Bovine Mastitis; Draft Guidance for Industry; Availability
- Food and Drug Administration Report and Plan on Best Practices for Guidance; Availability
- Food and Drug Administration's Best Practices for Food and Drug Administration Communication With Interested Parties: Draft Report for Public Comment; Availability
- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor
- Advancing Smoking Cessation: Food and Drug Administration and National Institutes of Health Priorities; Public Meeting; Request for Comments; Reopening of Public Comment Period
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product; KEBILIDI (eladocagene exuparvovec-tneq)
- Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologics License Application 761393 for Condoliase Injection
November 2024
- Use of Circulating Tumor Deoxyribonucleic Acid for Curative-Intent Solid Tumor Drug Development; Guidance for Industry; Availability
- Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators
- Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application
- Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices
- Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects; Draft Guidance for Industry; Availability
- Advisory Committee; Oncologic Drugs Advisory Committee; Renewal
- Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products; Draft Guidance for Industry; Availability
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substantial Equivalence Reports for Tobacco Products
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Tobacco Product Applications and Recordkeeping Requirements
- Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications
- Orthopedic Non-Spinal Bone Plates, Screws, and Washers-Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
- 510(k) Third Party Review Program and Third Party Emergency Use Authorization Review; Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability
- Development of an Enhanced Systematic Process for the Food and Drug Administration's Post-Market Assessment of Chemicals in Food; Public Meeting; Request for Comments; Extension of Comment Period
- Statement of Organization, Functions, and Delegations of Authority
- Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
- Per- and Polyfluoroalkyl Substances in Seafood; Request for Information
- Determination That NOXAFIL (Posaconazole) Delayed-Release Tablets, 100 Grams Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness; Correction
- Determination That IC-GREEN (Indocyanine Green), 25 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Miguel Angel Montalvo Villa: Final Debarment Order
- Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
- Determination That FORTESTA (Testosterone) Gel, 10 Milligrams/0.5 Gram Actuation, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Determination of Regulatory Review Period for Purposes of Patent Extension; AGILI-C
- Ivette Maria Portela Martinez: Final Debarment Order
- Pfizer, Inc., et al.; Withdrawal of Approval of 26 New Drug Applications
- Determination That JESDUVROQ (daprodustat) Tablets, 1 Milligram, 2 Milligrams, 4 Milligrams, 6 Milligrams, and 8 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Determination That HYDROCORTONE (Hydrocortisone Sodium Phosphate) Injection, Equivalent to 50 Milligrams Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Kevin Sheng Hsiang Fang: Final Debarment Order
- Frequently Asked Questions-Developing Potential Cellular and Gene Therapy Products; Draft Guidance for Industry; Availability
- Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug User Fee Program
- Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics; Draft Guidance for Industry; Availability
- Patient-Focused Drug Development: Workshop To Discuss Methodologic and Other Challenges Related to Patient Experience Data; Public Workshop; Request for Comments
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Produce Regulatory Program Standards
- Public Workshop on Optimizing the Use of Real-World Evidence in Regulatory Decision-Making for Drugs and Biological Products-Looking Forward; Request for Comments
- Determination That NUPLAZID (Pimavanserin Tartrate) Tablet, Equivalent 17 Milligram Base, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use
- Color Additive Certification; Increase in Fees for Certification Services
- Export Lists for Human Food: Request for Information
- Sec. 540.525 Scombrotoxin (Histamine)-Forming Fish and Fishery Products-Decomposition and Histamine (CPG 7108.24) Compliance Policy Guide; Guidance for Food and Drug Administration Staff; Availability
- Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2); Draft Guidance for Industry; Extension of Comment Period
- Reauthorization of the Over-The-Counter Monograph Drug User Fee Program; Public Meeting; Request for Comments
October 2024
- M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms; International Council for Harmonisation; Guidance for Industry; Availability
- Product-Specific Guidances; Revised Draft Guidances for Industry; Availability
- Environmental Defense Fund, et al.; Response to Objections and Requests for a Public Hearing
- Indirect Food Additives: Adhesives and Components of Coatings; Paper and Paperboard Components; Polymers; Adjuvants, Production Aids, and Sanitizers
- New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
- Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List
- Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination; Guidance for Industry; Availability
- Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
- Food and Drug Administration Enforcement Policy for Association of American Feed Control Officials-Defined Animal Feed Ingredients; Guidance for Industry; Availability
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adherence Potential and Patient Preference in Prescription Drug Promotion
- Agency Information Collection Activities; Proposed Collection; Comment Request; Antimicrobial Animal Drug Sales and Distribution
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Animal Food
- Drug Interaction Information in Human Prescription Drug and Biological Product Labeling-Content and Format; Draft Guidance for Industry; Availability
- Chemical Analysis for Biocompatibility Assessment of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period
- Determination of Regulatory Review Period for Purposes of Patent Extension; Vyndamax
- Determination of Regulatory Review Period for Purposes of Patent Extension; Vyndaqel
- Determination of Regulatory Review Period for Purposes of Patent Extension; Pascal Precision Transcatheter Valve Repair System
- Determination of Regulatory Review Period for Purposes of Patent Extension; Gore Tag Thoracic Branch Endoprosthesis
- Determination of Regulatory Review Period for Purposes of Patent Extension; Wavewriter Alpha Spinal Cord Stimulator System
- The Accreditation Scheme for Conformity Assessment Program: Draft Guidances for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff; Availability; Extension of Comment Period
- Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method; Draft Guidance for Industry; Availability
- Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments; Correction
- Determination That TAVIST (Clemastine Fumarate) Tablet, 2.68 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Review of Drug Master Files in Advance of Certain Abbreviated New Drug Application Submissions Under Generic Drug User Fee Amendments; Guidance for Industry; Availability
- Linde, Inc.; Withdrawal of Approval of a New Drug Application and New Animal Drug Application for Helium, USP
- Postoperative Nausea and Vomiting: Developing Drugs for Prevention; Draft Guidance for Industry; Availability
- Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Guidance for Industry; Availability
- Determination of Regulatory Review Period for Purposes of Patent Extension; EXXUA
- Core Patient-Reported Outcomes in Cancer Clinical Trials; Guidance for Industry; Availability
- Temporary Policies for Compounding Certain Parenteral Drug Products; Guidance for Industry; Availability
- Requests for Reconsideration at the Division Level Under the Generic Drug User Fee Amendments; Guidance for Industry; Availability
- Determination That NOXAFIL (Posaconazole) Delayed-Release Tablets, 100 Grams Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Revocation of Emergency Use of a Biological Product During the COVID-19 Pandemic; Availability
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product; MIPLYFFA (Arimoclomol)
- Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; KISQALI (ribociclib)
- Medical Devices; Quality System Regulation Amendments; Correction
- Using Relative Supersaturation To Support `Urinary Tract Health' Claims for Adult Maintenance Cat Food; Guidance for Industry; Availability
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product; AQNEURSA (Levacetylleucine)
- Endosseous Dental Implants and Endosseous Dental Implant Abutments-Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff; Availability
- Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2025 Proposed Guidance Development
- Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; TREMFYA (guselkumab)
- Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Supplemental Biologics License Application 125586/546 From AstraZeneca AB for Andexxa (Coagulation Factor Xa (Recombinant), Inactivated -zhzo); November 21, 2024
- Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers; Guidance for Industry; Availability
- Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-New Drug Application 210934 for Sotagliflozin Oral Tablet
- Determination That AUGMENTIN XR (Amoxicillin; Clavulanate Potassium) Extended-Release Tablets, 1 Gram; Equivalent to 62.5 Milligram Base, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Agency Information Collection Activities; Proposed Collection; Comment Request; Promotion of Prescription Drugs Within a Talk Show Format
- Center for Drug Evaluation and Research Quantitative Medicine Center of Excellence; Program Announcement
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic User Fee Payment Request Forms
September 2024
- Statement of Organization, Functions, and Delegations of Authority
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
- Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2); Draft Guidance for Industry; Availability
- Amended Environmental Assessment for Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada; Availability
- Safety and Performance Based Pathway Device-Specific Guidances; Guidance for Industry and Food and Drug Administration Staff; Availability
- Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment; Guidance for Industry and Food and Drug Administration Staff; Availability
- PHM Brands; Withdrawal of Food Additive Petition
- Determination of Regulatory Review Period for Purposes of Patent Extension; OGSIVEO
- Determination of Regulatory Review Period for Purposes of Patent Extension; OMLONTI
- Determination of Regulatory Review Period for Purposes of Patent Extension; JESDUVROQ
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Recall Authority
- Live Biotherapeutic Products To Prevent Necrotizing Enterocolitis in Very Low Birth Weight Infants; Public Workshop; Request for Comments
- Determination of Regulatory Review Period for Purposes of Patent Extension; ELUCIREM
- Determination of Regulatory Review Period for Purposes of Patent Extension; FRUZAQLA
- Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices
- Determination of Regulatory Review Period for Purposes of Patent Extension; DAYBUE
- Determination of Regulatory Review Period for Purposes of Patent Extension; ZAVZPRET
- Determination of Regulatory Review Period for Purposes of Patent Extension; QUVIVIQ
- Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability
- Determination of Regulatory Review Period for Purposes of Patent Extension; BRAVECTO; Correction
- Determination of Regulatory Review Period for Purposes of Patent Extension; OJJAARA
- Microbiology Devices; Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management
- Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Program
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
- The Accreditation Scheme for Conformity Assessment Program; Draft Guidances for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff; Availability
- Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement
- Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
- Determination of Regulatory Review Period for Purposes of Patent Extension; SYMDEKO
- Advancing Smoking Cessation: Food and Drug Administration and National Institutes of Health Priorities; Public Meeting; Request for Comments
- Progynon Associates, et al.; Withdrawal of Approval of Four New Drug Applications
- DSM Biomedical; Filing of Color Additive Petition
- Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments
- Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments
- Revocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community
- Chemical Analysis for Biocompatibility Assessment of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments: Strain Selection for Influenza Vaccines
- Allergan, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications
- Fee Rate for Using a Priority Review Voucher in Fiscal Year 2025
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Facility User Fee Cover Sheet, Form 3601a
- Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling Requirements for Prescription Drugs
- Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice; Draft Guidance for Industry; Availability
- Conducting Clinical Trials With Decentralized Elements; Guidance for Industry, Investigators, and Other Interested Parties Availability
- Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List; Revisions to the Withdrawn or Removed List
- Chemistry, Manufacturing, and Controls Technical Section Filing Strategies; Draft Guidance for Industry; Availability
- Considerations for Generating Clinical Evidence From Oncology Multiregional Clinical Development Programs; Draft Guidance for Industry; Availability
- Digital Health Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Total Product Lifecycle Considerations for Generative Artificial Intelligence-Enabled Medical Devices
- Medical Devices; Immunology and Microbiology Devices; Classification of the Quantitative Viral Nucleic Acid Test for Transplant Patient Management
- Determination of Regulatory Review Period for Purposes of Patent Extension; ORSERDU
- Determination of Regulatory Review Period for Purposes of Patent Extension; REZZAYO
- Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Clozapine Test System
- Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect or Measure Nucleic Acid From Viruses Associated With Head and Neck Cancers
- Electronic Common Technical Document; Data Standards; Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Supporting Electronic Common Technical Document Version 4.0
- Medical Devices; Therapeutic Devices; Classification of the Pediatric Continuous Renal Replacement Therapy System
- Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements; Guidance for Industry; Availability
- Sandoz Inc., et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications; Correction
- General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of Public Docket; Request for Comments-ProSense Cryoablation System
- New Drugs Regulatory Program Modernization: Integrated Assessment of Marketing Applications and Integrated Review Documentation; Request for Comments
- The Food and Drug Administration's Draft Strategy Document on Innovative Manufacturing Technologies
- Determination of Regulatory Review Period for Purposes of Patent Extension; ZTALMY
- Medical Devices; Immunology and Microbiology Devices; Classification of the Whole Exome Sequencing Constituent Device
- Determination of Regulatory Review Period for Purposes of Patent Extension; VOQUEZNA DUAL PAK-New Drug Application 215153
- Determination of Regulatory Review Period for Purposes of Patent Extension; VOQUEZNA TRIPLE PAK-New Drug Application 215152
- Determination of Regulatory Review Period for Purposes of Patent Extension; TECHNEGAS
- Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; OPZELURA (ruxolitinib)
- Determination of Regulatory Review Period for Purposes of Patent Extension; PLUVICTO
- Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Pancreatic Debridement Device
- Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Blood Collection Device for Cell-Free Nucleic Acids
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
- Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-New Drug Application 215244 for Elamipretide Hydrochloride Injection
- Agency Information Collection Activities; Proposed Collection; Comment Request; Pharmaceutical Distribution Supply Chain; Drug Supply Chain Security
- Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle; Guidance for Industry, Food and Drug Administration Staff and Other Interested Parties; Availability
- Medical Devices; Gastroenterology-Urology Devices; Classification of the Hemodialyzer With Expanded Solute Removal Profile
- Determination of Regulatory Review Period for Purposes of Patent Extension; YCANTH
- Determination of Regulatory Review Period for Purposes of Patent Extension; SEGLUROMET
- Determination of Regulatory Review Period for Purposes of Patent Extension; STEGLATRO
- Determination of Regulatory Review Period for Purposes of Patent Extension; STEGLUJAN
- Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Open Loop Fluid Therapy Recommender
- Medical Devices; Hematology and Pathology Devices; Classification of the Heparin and Direct Oral Factor Xa Inhibitor Drug Test System
- Food Additives Permitted in Feed and Drinking Water of Animals; Pichia Pastoris Dried Yeast
- Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution and Related Collections of Information
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation B12 Pediatric Device Survey
- Medical Devices; Dental Devices; Classification of the Radiofrequency Toothbrush
- Agency Information Collection Activities; Proposed Collection; Comment Request; Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities
- Medical Devices; Ophthalmic Devices; Classification of the Hydrophilic Re-Coating Solution
- Control of Nitrosamine Impurities in Human Drugs; Guidance for Industry; Availability
- Determination That FLAGYL (Metronidazole) Tablets, 250 Milligrams and 500 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Identifying Priority Focus Areas for Future Guidance Development and Engagement With Interested Parties in Model-Informed Drug Development; Request for Information
- Medical Devices; Neurological Devices; Classification of the Digital Therapy Device for Attention Deficit Hyperactivity Disorder
- Medical Devices; Physical Medicine Devices; Classification of the External Compression Device for Internal Jugular Vein Compression
- Revocation of Authorization of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
- Medical Devices; Dental Devices; Classification of the Neuromuscular Tongue Muscle Stimulator for the Reduction of Snoring and Obstructive Sleep Apnea
- Medical Devices; Orthopedic Devices; Classification of the Intervertebral Body Graft Containment Device
August 2024
- Prohibition of Sale of Tobacco Products to Persons Younger Than 21 Years of Age
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Restaurant and Retail Foodservice Facility Types
- Voluntary Malfunction Summary Reporting Program for Manufacturers; Guidance for Industry and Food and Drug Administration Staff; Availability
- Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting for Manufacturers
- Patient Engagement Advisory Committee; Notice of Meeting-Patient-Centered Informed Consent in Clinical Study
- Determination That FENTANYL CITRATE Injections, Equivalent to 2.5 Milligram Base/50 Milliliter and Equivalent to 5 Milligram Base/100 Milliliter, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product; LIVMARLI (maralixibat)
- Authorization of Emergency Use of a Freeze-Dried Plasma Product for Treatment of Hemorrhage or Coagulopathy During an Emergency Involving Agents of Military Combat; Availability
- Determination That DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% (Diltiazem Hydrochloride), 125 Milligrams/125 Milliliters (1 Milligram/Milliliter) and 250 Milligrams/250 Milliliters (1 Milligram/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Withdrawal of Approval and Amending of Mammography Quality Standards Act Alternative Standards
- Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide; Guidance for Industry and Food and Drug Administration Staff; Availability
- Final Decision on the Proposal To Refuse To Approve a New Drug Application for ITCA 650
- Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Immune Checkpoint Inhibitors in Patients With Unresectable or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma and Esophageal Squamous Cell Carcinoma
- Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability
- Electronic Submission Template for Medical Device De Novo Requests; Guidance for Industry and Food and Drug Administration Staff; Availability
- Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
- Food Additives Permitted in Feed and Drinking Water of Animals; Fermented Ammoniated Condensed Whey
- Predetermined Change Control Plans for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Determination That PENNSAID (Diclofenac Sodium) Topical Solution 2%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
- Product-Specific Guidance Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants Under the Generic Drug User Fee Amendments; Guidance for Industry; Availability
- Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods; Draft Guidance for Industry (Edition 2); Availability
- Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Selected Microbial Agents That Cause Acute Febrile Illness
- Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Nucleic Acid Targets Including SARS-CoV-2 in Respiratory Specimens
- Medical Devices; General Hospital and Personal Use Devices; Classification of the Intravenous Catheter Force-Activated Separation Device
- Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products
- Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting
- Determination of Regulatory Review Period for Purposes of Patent Extension; MIEBO
- Ryan Stabile: Final Debarment Order
- Cubist Pharmaceuticals LLC; Withdrawal of Approval of a New Drug Application for ENTEREG (Alvimopan) Capsules, 12 Milligrams
- Agency Information Collection Activities; Proposed Collection; Comment Request; Laboratory Accreditation for Analyses of Foods
- International Drug Scheduling; Single Convention on Narcotic Drugs; Convention on Psychotropic Substances; Hexahydrocannabinol; N-Pyrrolidino Protonitazene (Protonitazepyne); N-Pyrrolidino Metonitazene (Metonitazepyne); N-Piperidinyl Etonitazene (Etonitazepipne); N-Desethyl-isotonitazene; 3-Hydroxy-phencyclidine; N-Ethylheptedrone; Carisoprodol; Request for Comments
- Advisory Committee; Peripheral and Central Nervous System Drugs Advisory Committee; Renewal
- Development of an Enhanced Systematic Process for the Food and Drug Administration's Post-Market Assessment of Chemicals in Food; Public Meeting; Request for Comments
- Agency Information Collection Activities; Proposed Collection; Risk/Safety Considerations and Motivations for Purchase and Use of Kratom and Psychedelics Alone and in Combination With Other Substances; Withdrawal of Notice
- Advancing Rare Disease Therapies Through a Food and Drug Administration Rare Disease Innovation Hub; Public Meeting; Request for Comments
- Gastrointestinal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Supplemental New Drug Application 207999 S-011 for OCALIVA (obeticholic acid) Oral Tablets
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
- Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drug and Biological Products for Treatment; Revised Draft Guidance for Industry; Availability
- Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Psychopharmacologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Clozapine Risk Evaluation and Mitigation Strategy
- Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases; Guidance for Industry; Availability
- Animal Food Ingredient Consultation; Draft Guidance for Industry; Availability
- Pre-Market Animal Food Ingredient Review Programs; Request for Comments
- Food and Drug Administration Enforcement Policy for Association of American Feed Control Officials-Defined Animal Feed Ingredients; Draft Guidance for Industry; Availability
- Determination of Regulatory Review Period for Purposes of Patent Extension; VANFLYTA
- Determination of Regulatory Review Period for Purposes of Patent Extension; REZLIDHIA
- Flamingo Pharmaceuticals Ltd.; Proposal To Withdraw Approval of Two Abbreviated New Drug Applications; Opportunity for a Hearing
- Advisory Committee; Blood Products Advisory Committee; Renewal
- Determination of Regulatory Review Period for Purposes of Patent Extension; INPEFA
- Office of Pharmaceutical Quality Experiential Learning Site Visit Program; Program Announcement
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Cosmetic Export Certificate Application Process
- Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-New Drug Application 213972 for Sulopenem Etzadroxil/Probenecid Tablets
- Determination of Regulatory Review Period for Purposes of Patent Extension; TALZENNA
- Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Reopening the Comment Period
- Agency Information Collection Activities; Proposed Collection; Comment Request; Healthcare Provider Survey of Topics Related to Prescription Drug Promotion
- Determination of Regulatory Review Period for Purposes of Patent Extension; XOFLUZA
- Determination That DELATESTRYL (Testosterone Enanthate) Injection, 200 Milligrams/Milliliter, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Determination That CIPRO (Ciprofloxacin Hydrochloride) Tablet, Equivalent to 100 Milligrams Base, Was Withdrawn From Sale for Reasons of Safety or Effectiveness
- Enhancing Diversity in Therapeutics Development for Pediatric Patients; Public Workshop
- GNT USA, LLC; Filing of Color Additive Petition
- Advisory Committee; Drug Safety and Risk Management Advisory Committee; Renewal
- Advisory Committee; Anesthetic and Analgesic Drug Products Advisory Committee; Renewal
- Advisory Committee; Psychopharmacologic Drugs Advisory Committee; Renewal
- Agency Information Collection Activities; Proposed Collection; Comment Request: Risk/Safety Considerations and Motivations for Purchase and Use of Kratom and Psychedelics Alone and in Combination With Other Substances
- M12 Drug Interaction Studies; M12 Drug Interaction Studies: Questions and Answers; International Council for Harmonisation; Guidances for Industry; Availability
July 2024
- Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Quantitative Testing for the Development of Food and Drug Administration Communications
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Principle
- Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Food Safety and Nutrition Survey
- Prescription Drug User Fee Rates for Fiscal Year 2025
- Outsourcing Facility Fee Rates for Fiscal Year 2025
- Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2025
- Over-the-Counter Monograph Drug User Fee Program-OTC Monograph Order Request Fee Rates for Fiscal Year 2025
- Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2025
- Medical Device User Fee Rates for Fiscal Year 2025
- Biosimilar User Fee Rates for Fiscal Year 2025
- Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2025
- Food Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2025
- Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2025
- Generic Drug User Fee Rates for Fiscal Year 2025
- Advisory Committee; Pharmacy Compounding Advisory Committee; Renewal
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; National Agriculture and Food Defense Strategy Survey
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Plant Varieties Intended for Food Use
- Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
- Fosun Pharma USA Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications
- Advisory Committee; Pulmonary-Allergy Drugs Advisory Committee; Renewal
- Filing of Food Additive Petition From Environmental Defense Fund, Breast Cancer Prevention Partners, Center for Food Safety, Environmental Working Group, Tom Neltner, and Maricel Maffini; Request To Amend the Food Additive Regulations To Remove Authorization of Fluorinated Polyethylene; Reopening of the Comment Period; Correction
- Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry; Availability
- Revocation of Authorization of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
- Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products; Establishment of a Public Docket; Request for Information and Comments
- Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability
- Providing Over-the-Counter Monograph Submissions in Electronic Format; Guidance for Industry; Availability
- Biosimilar Product Development Guidance; Establishment of a Public Docket; Request for Information and Comments
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision 2); Guidance for Industry; Availability
- Food and Drug Administration Information Technology Strategy and Customer Experience Strategy; Request for Comments; Extension of Comment Period
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising
- Agency Information Collection Activities; Proposed Collection; Comment Request; Microbiological Testing and Corrective Measures for Bottled Water
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Under the Federal Import Milk Act
- Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Draft Guidance for Industry; Availability
- Agency Information Collection Activities; Proposed Collection; Comment Request; Diversity Action Plans for Clinical Studies
- Determination of Regulatory Review Period for Purposes of Patent Extension; XENPOZYME; Correction
- Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma; Guidance for Industry; Availability
- Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
- Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy; Guidance for Industry; Availability
- Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies; Guidance for Industry; Availability
- Phytolon Ltd.; Filing of Color Additive Petition
- Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; VYVGART HYTRULO (efgartigimod alfa and hyaluronidase-qvfc)
- Platform Technology Designation Program; Draft Guidance for Industry; Extension of Comment Period
- Agency Information Collection Activities; Proposed Collection; Comment Request; Substantial Equivalence Reports for Tobacco Products
- Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Tobacco Product Applications and Recordkeeping Requirements
- Cellular and Gene Therapies Interactive Site Tours Program for Regulatory Project Managers and Reviewers; Information Available to Industry
- Takeda Pharmaceuticals U.S.A., Inc.; Withdrawal of Approval of New Drug Application for EXKIVITY (Mobocertinib Succinate) Capsule, Equivalent to 40 Milligrams Base
- Dental Composite Resin Devices and Dental Curing Lights-Premarket Notification (510(k)) Submissions Guidances; Draft Guidances for Industry and Food and Drug Administration Staff; Availability
- Clinical Considerations for Studies of Devices Intended To Treat Opioid Use Disorder; Guidance for Industry and Food and Drug Administration Staff; Availability
- Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar or Interchangeable Biosimilar Applicant
- Determination of Regulatory Review Period for Purposes of Patent Extension; SPEVIGO
- Workshop To Consider Artificial Intelligence in Drug and Biological Product Development; Public Workshop
- Genetic Metabolic Diseases Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-New Drug Application 214927, for Arimoclomol
- Advisory Committee; Allergenic Products Advisory Committee; Termination; Removal From List of Standing Committees
- Agency Information Collection Activities; Proposed Collection; Comment Request; Reclassification Petitions for Medical Devices
- Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products and Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Request for Applications for New Members of the Clinical Trials Transformation Initiative/Food and Drug Administration Patient Engagement Collaborative
- Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Investigational Use
- Authorization of Emergency Use of Monkeypox Polymerase Chain Reaction Test Home Collection Kit in Response to an Outbreak of Mpox; Availability
- Determination of Regulatory Review Period for Purposes of Patent Extension; Imjudo
- M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines; International Council for Harmonisation; Draft Guidance for Industry; Availability
- Authorization of Emergency Use of an In Vitro Diagnostic Device in Response to an Outbreak of Mpox; Availability
- Determination of Regulatory Review Period for Purposes of Patent Extension; VABYSMO
- Determination of Regulatory Review Period for Purposes of Patent Extension; RYSTIGGO
- Determination of Regulatory Review Period for Purposes of Patent Extension; LUNSUMIO
- Determination of Regulatory Review Period for Purposes of Patent Extension; ENJAYMO
- Determination of Regulatory Review Period for Purposes of Patent Extension; DAXXIFY
- Revocation of Authorization for Use of Brominated Vegetable Oil in Food
- Determination of Regulatory Review Period for Purposes of Patent Extension; VYVGART
- Determination of Regulatory Review Period for Purposes of Patent Extension; TECVAYLI
- Determination of Regulatory Review Period for Purposes of Patent Extension; ELFABRIO
- Determination of Regulatory Review Period for Purposes of Patent Extension; XENPOZYME
- Determination of Regulatory Review Period for Purposes of Patent Extension; KIMMTRAK
- Determination of Regulatory Review Period for Purposes of Patent Extension; ZYNYZ
- Determination of Regulatory Review Period for Purposes of Patent Extension; TEZSPIRE
- Essential Drug Delivery Outputs for Devices Intended To Deliver Drugs and Biological Products; Draft Guidance for Industry; Availability
June 2024
- Diversity Action Plans To Improve Enrollment of Participants From Underrepresented Populations in Clinical Studies; Draft Guidance for Industry; Availability
- Agency Information Collection Activities; Proposed Collection; Comment Request; Produce Regulatory Program Standards
- Priority Zoonotic Animal Drug Designation and Review Process; Guidance for Industry; Availability
- Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs; Guidance for Industry; Availability
- Food and Drug Administration Information Technology Strategy and Customer Experience Strategy; Request for Comments
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Total Product Life Cycle Advisory Program Pilot
- Laboratory Developed Tests: Small Entity Compliance Guide; Guidance for Laboratory Manufacturers and Food and Drug Administration Staff; Availability
- Best Practices for Meeting Management; Public Workshop; Request for Comments
- Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 062
- Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use; Draft Guidance for Industry; Availability
- Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles; Draft Guidance for Industry; Availability
- Determination That INVEGA (Paliperidone) Extended-Release Tablet, 1.5 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Considerations in Demonstrating Interchangeability With a Reference Product: Update; Draft Guidance for Industry; Availability
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
- Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications
- Human User Safety in New and Abbreviated New Animal Drug Applications; Guidance for Industry; Availability
- SpecGX, LLC, et al.; Withdrawal of Approval of 30 Abbreviated New Drug Applications; Correction
- Sandoz Inc., et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications
- Request for Nominations From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on Public Advisory Committees
- Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection; Guidance for Industry, Revision 1; Availability
- Medicated Feed Mill License; Veterinary Feed Directive Drugs; Change of Address
- Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting; Guidance for Industry; Availability
- Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases
- First Annual Animal Drug User Fee Educational Conference; Public Meeting
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Enforcement Notifications
- Facility Readiness: Goal Date Decisions Under Generic Drug User Fee Amendments; Guidance for Industry; Availability
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1); Draft Guidance for Industry; Correction
- Requirements for Additional Traceability Records for Certain Foods; Proposed Exemption for Cottage Cheese Regulated by the National Conference on Interstate Milk Shipments Grade “A” Pasteurized Milk Ordinance
- Diabetic Foot Infections: Developing Drugs for Treatment; Guidance for Industry; Availability
- Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics; Guidance for Industry; Availability
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Veterinary Feed Directive
- Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use
- Richard B. Smith III: Final Debarment Order
- Jonathan R. Shaver: Final Debarment Order
- Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
- Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
- The Tobacco Products Scientific Advisory Committee; Notice of Meeting; Amendment of Notice
- Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under the Federal Food, Drug, and Cosmetic Act; Notice; Request for Information and Comments; Reopening of the Comment Period
- Emerging Drug Safety Technology Meetings; Program Announcement
- Advisory Committee; Arthritis Advisory Committee; Renewal
- Advisory Committee; Obstetrics, Reproductive and Urologic Drugs Advisory; Renewal
- Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Supplemental Biologics License Application 761069/S-043 for IMFINZI (durvalumab) Injection
- Food Additives Permitted in Feed and Drinking Water of Animals; Ethyl Cellulose
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Irradiation in the Production, Processing, and Handling of Food
- Proposal To Refuse To Approve a New Drug Application Supplement for HETLIOZ (Tasimelteon); Opportunity for a Hearing
- Marina Sievert: Final Debarment Order
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Record Retention Requirements for the Soy Protein and Reduced Risk of Coronary Heart Disease Health Claim
- Processes and Practices Applicable to Bioresearch Monitoring Inspections; Draft Guidance for Industry; Availability
- Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Animal Food
- Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority
- Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring Inspections for Center for Biologics Evaluation and Research Submissions; Draft Guidance for Industry; Availability
- Statement of Organization, Functions, and Delegations of Authority
- Laboratory Accreditation for Analyses of Foods; Program Implementation; Determination of Sufficient Laboratory Capacity for Import-Related Food Testing Covered by the Regulation
- Shanif Abdul Punjani: Final Debarment Order
- Pfizer, Inc., et al.; Withdrawal of Approval of 23 New Drug Applications
- Michael Terry Little: Final Debarment Order
May 2024
- Administrative Destruction
- Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Appendix 1; Extension of Comment Period
- Advisory Committee; Science Advisory Board to the National Center for Toxicological Research; Termination; Removal From List of Standing Committees
- Platform Technology Designation Program; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
- Bayer HealthCare Pharmaceuticals, Inc., et al.; Withdrawal of Approval of Three New Drug Applications
- Maria Anzures-Camarena: Final Debarment Order
- Agency Information Collection Activities; Proposed Collection; Comment Request; De Novo Classification Process (Evaluation of Automatic Class III Designation)
- Jessica Palacio; Denial of Hearing; Final Debarment Order
- Progynon Associates, et al.; Proposal to Withdraw Approval of Four New Drug Applications; Opportunity for a Hearing
- Color Additive Certification; Increase in Fees for Certification Services; Extension of the Comment Period
- Authorization of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability
- Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product; PAXLOVID
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1); Draft Guidance for Industry; Availability
- Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
- Vaccines and Related Biological Products Advisory Committee; Amendment of Notice-Selection of the 2024 to 2025 Formula for COVID-19 Vaccines
- Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products; Public Workshop
- Labeling Requirements for Approved or Conditionally Approved New Animal Drugs; Extension of Comment Period
- Agency Information Collection Activities; Proposed Collection; Comment Request; Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation B12 Pediatric Device Survey
- Agency Information Collection Activities; Proposed Collection; Comment Request; Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Principle
- Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device
- Program Policy and Procedures Manual Guide 1240.3605 Regulating Animal Foods With Drug Claims; Withdrawal
- Lonza Greenwood LLC; Filing of Color Additive Petition
- Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
- Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
- Helsinn Healthcare SA; Withdrawal of Approval of New Drug Application for TRUSELTIQ (Infigratinib Phosphate) Capsules, 25 Milligrams and 100 Milligrams
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product; XOLREMDI (mavorixafor)
- Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product; OJEMDA (tovorafenib)
- Gina Acosta: Final Debarment Order
- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications, Change of Sponsor, Change of Sponsor Address
- Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
- Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Cosmetic Export Certificate Application Process
- Determination of Regulatory Review Period for Purposes of Patent Extension; JEMPERLI
- Modified Risk Tobacco Product Application: Renewal Applications for IQOS 2.4 System Holder and Charger, Marlboro Amber HeatSticks, Marlboro Green Menthol HeatSticks, and Marlboro Blue Menthol HeatSticks, Heated Tobacco Products and Heated Tobacco Product Consumables, Submitted by Philip Morris Products S.A.
- Modified Risk Tobacco Product Application: Renewal Application for IQOS 3.0 System Holder and Charger, Heated Tobacco Product, Submitted by Philip Morris Products S.A.
- Remanufacturing of Medical Devices; Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff; Availability
- Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologics License Application 761248, for Donanemab Solution for Intravenous Infusion
- Psychopharmacologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Midomafetamine Capsules
- Statement of Organization, Functions, and Delegations of Authority
- Statement of Organization, Functions, and Delegations of Authority
- Fresenius Kabi USA, LLC, et. al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications
- Adam Paul Runsdorf: Final Debarment Order
- Risk Evaluation and Mitigation Strategy Logic Model: A Framework to Link Program Design With Assessment; Draft Guidance for Industry; Availability
- Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564; Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff; Availability
- Medical Devices; Laboratory Developed Tests
- Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Pharmaceutical Development; Draft Guidance for Industry; Availability
- The Tobacco Products Scientific Advisory Committee; Notice of Meeting
- Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach; Guidance for Industry; Availability
- Heritable Intentional Genomic Alterations in Animals: The Approval Process; Draft Guidance for Industry; Availability
- Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Investigational Use
- Angela Maria Giron: Final Debarment Order
- Request for Nominations of a Nonvoting Representative of the Interest of Tobacco Growers on the Tobacco Products Scientific Advisory Committee
April 2024
- Listening Session: Optimizing the Food and Drug Administration's Use of and Processes for Advisory Committees; Public Meeting; Request for Comments
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Recall Regulations
- Considerations for the Use of Human-and Animal-Derived Materials and Components in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products; Draft Guidance for Industry; Availability
- Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products; Draft Guidance for Industry; Availability
- Revocation of Uses of Partially Hydrogenated Oils in Foods: Guidance for Industry; Small Entity Compliance Guide; Availability
- Determination That FLUDARABINE PHOSPHATE Injection, 50 Milligrams/2 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Food Additives Permitted in Feed and Drinking Water of Animals; Condensed, Extracted Glutamic Acid Fermentation Product
- Veterinary Feed Directive Regulation Questions and Answers; Small Entity Compliance Guide; Guidance for Industry (Revised); Availability
- Raw Data for Safety and Effectiveness Studies; Draft Guidance for Industry; Availability
- Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in New Drug Applications and Abbreviated New Drug Applications; Draft Guidance for Industry; Availability
- Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologics License Application 761326 for NNC0148-0287 Injection (Insulin Icodec)
- Color Additive Certification; Increase in Fees for Certification Services; Reopening of the Comment Period
- Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination and Removal of a Foreign Manufacturer's Goods From Detention Without Physical Examination; Draft Guidance for Industry; Reopening of the Comment Period
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Electronic Records: Electronic Signatures
- Promoting Effective Drug Development: Identifying Opportunities and Priorities for the Food and Drug Administration's Office of Clinical Pharmacology; Request for Comments
- Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic User Fee Payment Request Forms
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Shortages Data Collections
- Filing of Food Additive Petition From Environmental Defense Fund, Breast Cancer Prevention Partners, Center for Food Safety, Environmental Working Group, Tom Neltner, and Maricel Maffini; Request To Amend the Food Additive Regulations To Remove Authorization of Fluorinated Polyethylene
- Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of Healthcare Providers To Advance Pregnancy Safety Data Collection and Improve Health Communications
- Cancer Clinical Trial Eligibility Criteria: Performance Status; Draft Guidance for Industry, Institutional Review Boards, Clinical Investigators; Availability
- Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Draft Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability
- Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Draft Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability
- Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers; Revised Draft Guidance for Industry; Availability
- Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability
- Agency Information Collection Activities; Proposed Collection; Comment Request; Data To Support Social and Behavioral Research as Used by the Food and Drug Administration
- Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting-Guardant Shield Blood Collection Kit
- PAI Holdings, LLC DBA Pharmaceutical Associates, Inc., et al.; Withdrawal of Approval of 23 New Drug Applications
- Final Decision on Withdrawal of PEPAXTO (melphalan flufenamide) Following Appeal of the Proposal To Withdraw Approval; Availability of Final Decision
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product; LENMELDY (Atidarsagene Autotemcel)
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expedited Programs for Serious Conditions-Drugs and Biologics
- Center for Drug Evaluation and Research Center for Clinical Trial Innovation
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product; DUVYZAT (givinostat)
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling Requirements: Calorie Labeling of Articles of Food in Vending Machines and Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Allergen Labeling and Reporting
- Determination That VISTARIL (Hydroxyzine Pamoate) Oral Suspension, 25 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Determination That KEMSTRO (Baclofen) Orally Disintegrating Tablets, 10 Milligrams and 20 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; Public Meeting; Request for Comments
- Determination That NALFON (Fenoprofen Calcium) Oral Capsules, Equivalent to 300 Milligram Base, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- 21st Century Cures Act: Annual Compilation of Notices of Updates From the Susceptibility Test Interpretive Criteria Web Page; Request for Comments
- Request for Nominations for Voting Members for the Patient Engagement Advisory Committee
- Request for Nominations on Device Good Manufacturing Practice Advisory Committee
- Determination That GLUCOTROL (Glipizide) Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Robert Lance Shuffert: Final Debarment Order
- Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-General Topic
- New Dietary Ingredient Notification Master Files for Dietary Supplements; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Comment Request
- Product-Specific Guidance for Oxymetazoline Hydrochloride; Draft Guidance for Industry; Availability
- Data Integrity for In Vivo Bioavailability and Bioequivalence Studies; Draft Guidance for Industry; Availability
- Electronic Submission of Expedited Safety Reports From Investigational New Drug-Exempt Bioavailability/Bioequivalence Studies; Guidance for Industry; Availability
- Providing Regulatory Submissions in Electronic Format: Investigational New Drug Application Safety Reports; Guidance for Industry; Availability
March 2024
- Over-the-Counter Monograph Drug User Fee Program-Facility Fee Rates for Fiscal Year 2024
- SpecGX LLC, et al.; Withdrawal of Approval of 30 Abbreviated New Drug Applications
- Animal Studies for Dental Bone Grafting Material Devices-Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Cattle Materials Prohibited From Use in Animal Food or Feed
- Handling and Retention of Bioavailability and Bioequivalence Testing Samples; Guidance for Industry (Part Draft, Part Final); Availability
- Banned Devices; Proposal To Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
- Phillip Leonowens: Final Debarment Order
- Electronic Submissions: Data Standards; Support and Requirement for the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data Implementation Guide-Animal Rule Version 1.0
- AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of New Drug Application for LYNPARZA (Olaparib) Capsules
- Clovis Oncology, Inc., AstraZeneca Pharmaceuticals LP, and GlaxoSmithKline LLC; Withdrawal of Approval of the Indications for Advanced Ovarian Cancer for Poly (ADP-Ribose) Polymerase Inhibitors RUBRACA (Rucaparib) Tablets, LYNPARZA (Olaparib) Tablets, and ZEJULA (Niraparib) Capsules
- Determination That ISUPREL (Isoproterenol Hydrochloride) Injection, 0.2 Milligrams per Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Use of Minimal Residual Disease as an Endpoint in Multiple Myeloma Clinical Trials
- Agency Information Collection Activities; Proposed Collection; Comment Request; National Agriculture and Food Defense Strategy Survey
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Reporting and Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle
- Martin Valdes: Final Debarment Order
- Food Additives: Food Contact Substance Notification That Is No Longer Effective
- Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Extension of Comment Period
- Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products; Draft Guidance for Industry; Availability
- Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Total Product Life Cycle Advisory Program Pilot
- Revocation of Six Authorizations of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
- Willis Reed: Final Debarment Order
- Eli Lilly and Company; Withdrawal of Approval of SARAFEM (Fluoxetine Hydrochloride) Capsules, Equivalent to 10 Milligrams Base and Equivalent to 20 Milligrams Base, Including the Premenstrual Dysphoric Disorder Indication Approved Under New Drug Application 018936
- Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed Directive
- Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Under the Federal Import Milk Act
- Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act
- Air Products and Chemicals, Inc.; Withdrawal of Approval of a New Drug Application and New Animal Drug Application for Helium, USP
- Bayer HealthCare Pharmaceuticals Inc.; Withdrawal of Approval of New Drug Application for ALIQOPA (Copanlisib) for Injection, 60 Milligrams per Vial
- Pharmacokinetics in Patients With Impaired Renal Function-Study Design, Data Analysis, and Impact on Dosing; Guidance for Industry; Availability
- Manufacture of Batches in Support of Original New Animal Drug Applications, Abbreviated New Animal Drug Applications, and Conditional New Animal Drug Applications; Draft Guidance for Industry; Availability
- Controlled Correspondence Related to Generic Drug Development; Guidance for Industry; Availability
- Early Alzheimer's Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
- Frozen Cherry Pie; Revocation of a Standard of Identity and a Standard of Quality
- Medical Devices; Technical Amendments
- Determination That DUEXIS (Ibuprofen and Famotidine) Tablet, 800 Milligrams and 26.6 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Determination That NUCYNTA (Tapentadol Hydrochloride) Solution, Equivalent 20 Milligrams Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Evaluation of Thermal Effects of Medical Devices That Produce Tissue Heating and/or Cooling; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports; International Council for Harmonisation; Draft Guidance for Industry; Availability
- Determination of Regulatory Review Period for Purposes of Patent Extension; PYRUKYND
- Determination of Regulatory Review Period for Purposes of Patent Extension; VTAMA
- Determination of Regulatory Review Period for Purposes of Patent Extension; CIBINQO
- Hoffmann-La Roche, Inc., et al.; Withdrawal of Approval of Two New Drug Applications; Correction
- Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products; Draft Guidance for Industry; Availability
- Agency Information Collection Activities; Proposed Collection; Comment Request; Proposed Small Dispensers Assessment Under the Drug Supply Chain Security Act
- Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Determination That Romidepsin Injection, 10 Milligrams/2 Milliliters (5 Milligrams/Milliliter) and 27.5 Milligrams/5.5 Milliliters (5 Milligrams/Milliliter), Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Determination of Regulatory Review Period for Purposes of Patent Extension; DAURISMO
- Labeling Requirements for Approved or Conditionally Approved New Animal Drugs
- Early Alzheimer's Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
- Determination of Regulatory Review Period for Purposes of Patent Extension; Light Adjustable Lens
- Agency Information Collection Activities; Proposed Collection; Comment Request; Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
- Filing of Color Additive Petition From Phytolon Ltd.
- Advisory Committee; Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Renewal
- Agency Information Collection Activities; Proposed Collection; Comment Request; New Plant Varieties Intended for Food Use
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records
- Blood Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Strategies for Testing Blood Donations for Malaria Infection
- Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment; Guidance for Industry; Correction
- Revocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability
- Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development; International Council for Harmonisation; Guidances for Industry; Availability
- Advisory Committee; Gastrointestinal Drugs Advisory Committee; Renewal
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Food and Drug Administration Approval to Market a New Drug
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data To Support Drug Product Communications as Used by the Food and Drug Administration
- Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry; Availability
- Agency Information Collection Activities; Proposed Collection; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Restaurant and Retail Foodservice Facility Types
- Notice of the Denial of a Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon)
- Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Addition to List of Standing Committees
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; The Real Cost Monthly Implementation Assessment
- Determination of Regulatory Review Period for Purposes of Patent Extension; SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE SYSTEM
- Determination of Regulatory Review Period for Purposes of Patent Extension; VOXZOGO
- Determination of Regulatory Review Period for Purposes of Patent Extension; RELYVRIO
- Determination of Regulatory Review Period for Purposes of Patent Extension; FYARRO
- Determination of Regulatory Review Period for Purposes of Patent Extension; SOTYKTU
- Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments: Selection of Strain(s) To Be Included in the 2024 to 2025 Formula for COVID-19 Vaccines
- Clinical Pharmacology Considerations for Antibody-Drug Conjugates; Guidance for Industry; Availability
- Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 061
- Key Information and Facilitating Understanding in Informed Consent; Draft Guidance for Sponsors, Investigators, and Institutional Review Boards; Availability
February 2024
- Determination of Regulatory Review Period for Purposes of Patent Extension; BREXAFEMME
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export Certificates for Food and Drug Administration Regulated Products
- Determination of Regulatory Review Period for Purposes of Patent Extension; RECORLEV
- Determination of Regulatory Review Period for Purposes of Patent Extension; MOUNJARO
- Determination of Regulatory Review Period for Purposes of Patent Extension; VONJO
- Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Facility User Fee Cover Sheet, Form 3601a
- Determination of Regulatory Review Period for Purposes of Patent Extension; CAMZYOS
- Timothy Baxter; Final Order Announcing Termination Date of Debarment
- Determination of Regulatory Review Period for Purposes of Patent Extension; SAPHNELO
- Determination of Regulatory Review Period for Purposes of Patent Extension; EPI-SENSE GUIDED COAGULATION SYSTEM
- Determination of Regulatory Review Period for Purposes of Patent Extension; TEMBEXA
- Determination of Regulatory Review Period for Purposes of Patent Extension; AMPLATZER AMULET
- Determination of Regulatory Review Period for Purposes of Patent Extension; EVKEEZA
- Determination of Regulatory Review Period for Purposes of Patent Extension; SOGROYA
- Determination of Regulatory Review Period for Purposes of Patent Extension; ADUHELM
- Determination of Regulatory Review Period for Purposes of Patent Extension; EVRYSDI
- Determination of Regulatory Review Period for Purposes of Patent Extension; CAMCEVI
- Determination of Regulatory Review Period for Purposes of Patent Extension; OPDUALAG
- Determination of Regulatory Review Period for Purposes of Patent Extension; GEMTESA
- Determination of Regulatory Review Period for Purposes of Patent Extension; VEKLURY
- Determination of Regulatory Review Period for Purposes of Patent Extension; NULIBRY
- Determination of Regulatory Review Period for Purposes of Patent Extension; XERAVA
- Determination of Regulatory Review Period for Purposes of Patent Extension; PREVNAR-20
- Determination of Regulatory Review Period for Purposes of Patent Extension; LEQVIO
- Determination of Regulatory Review Period for Purposes of Patent Extension; ISTURISA
- Determination of Regulatory Review Period for Purposes of Patent Extension; KLISYRI
- Determination of Regulatory Review Period for Purposes of Patent Extension; ONGENTYS
- Determination of Regulatory Review Period for Purposes of Patent Extension; INQOVI
- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications, Change of Sponsor, Change of Sponsor Address
- Determination of Regulatory Review Period for Purposes of Patent Extension; Rybrevant
- User Fees; Technical Amendment
- Taylor McLaren: Final Debarment Order
- Advisory Committee; Digital Health Advisory Committee; Addition to List of Standing Committees
- Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
- Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment; Guidance for Industry; Availability
- Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Extension of Comment Period
- Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
- Request for Nominations for Voting Members for the Genetic Metabolic Diseases Advisory Committee; Amendment of Notice
- Statement of Organization, Functions, and Delegations of Authority
- Charging for Investigational Drugs Under an Investigational New Drug Application: Questions and Answers; Guidance for Industry; Availability
- Determination of Regulatory Review Period for Purposes of Patent Extension; QULIPTA
- Ross Lucien: Final Debarment Order
- Determination of Regulatory Review Period for Purposes of Patent Extension; WINLEVI
- Determination of Regulatory Review Period for Purposes of Patent Extension; SIMPLIFY CERVICAL ARTIFICIAL DISC
- Determination of Regulatory Review Period for Purposes of Patent Extension; VIVISTIM SYSTEM
- Determination of Regulatory Review Period for Purposes of Patent Extension; REACTIV8 SYSTEM
- Determination of Regulatory Review Period for Purposes of Patent Extension; ORGAN CARE SYSTEM HEART
- Determination of Regulatory Review Period for Purposes of Patent Extension; PORTICO TRANSCATHETER AORTIC VALVE IMPLANT
- Determination of Regulatory Review Period for Purposes of Patent Extension; ERVEBO
- Determination of Regulatory Review Period for Purposes of Patent Extension; SKYTROFA
- Determination of Regulatory Review Period for Purposes of Patent Extension; TACK ENDOVASCULAR SYSTEM (4F, 1.5-4.5 MILLIMETERS)
- Determination of Regulatory Review Period for Purposes of Patent Extension; ORGAN CARE SYSTEM LIVER
- Kalpen D. Patel: Final Debarment Order
- Training Program for Regulatory Project Managers; Information Available to Industry
- Use of Data Monitoring Committees in Clinical Trials; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
- Biologics License Applications and Master Files
- Advanced Manufacturing Technologies Designation Program; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Extension of Comment Period
- Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination and Removal of a Foreign Manufacturer's Goods From Detention Without Physical Examination; Draft Guidance for Industry; Availability
- Fiscal Year 2024 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments
- Brendon Gagne: Final Debarment Order
- Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
- Determination That QMIIZ (Meloxicam) Orally Disintegrating Tablets, 7.5 Milligrams and 15 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; Butonitazene; 3-Chloromethcathinone; Dipentylone; 2-Fluorodeschloroketamine; Bromazolam; Request for Comments
- Sensient Colors, LLC.; Filing of Color Additive Petition
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
- Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
- Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting-FSYX Ocular Pressure Adjusting Pump System
- Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
- Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
- Medical Devices; Quality System Regulation Amendments
- Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability
January 2024
- Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization; Guidance for Industry; Correction
- Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for Food and Drug Administration-Regulated Medical Products; Draft Guidance for Industry; Availability
- Human Gene Therapy Products Incorporating Human Genome Editing; Guidance for Industry; Availability
- Considerations for the Development of Chimeric Antigen Receptor T Cell Products; Guidance for Industry; Availability
- Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate
- Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
- Statement of Organization, Functions, and Delegations of Authority
- Best Practices for Food and Drug Administration Staff in the Postmarketing Safety Surveillance of Human Drug and Biological Products; Final Document; Availability
- Advisory Committee; Vaccines and Related Biological Products Advisory Committee, Renewal
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle
- Conducting Remote Regulatory Assessments-Questions and Answers; Revised Draft Guidance for Industry; Availability
- Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program
- Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability
- Determination of Regulatory Review Period for Purposes of Patent Extension; VOCABRIA
- Determination of Regulatory Review Period for Purposes of Patent Extension; CABENUVA
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products; Draft Guidance for Industry; Availability
- Revising Abbreviated New Drug Application Labeling Following Revision of the Reference Listed Drug Labeling; Final Guidance for Industry; Availability
- Listing of Color Additives Exempt From Certification; Jagua (Genipin-Glycine) Blue; Confirmation of Effective Date
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
- Request for Nominations From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Cellular, Tissue, and Gene Therapies Advisory Committee
- Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher
- Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher
- Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher
- Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
- Agency Information Collection Activities; Proposed Collection; Comment Request; State Enforcement Notifications
- Agency Information Collection Activities; Proposed Collection; Comment Request; Record Retention Requirements for the Soy Protein and Reduced Risk of Coronary Heart Disease Health Claim
- Agency Information Collection Activities; Proposed Collection; Comment Request; Irradiation in the Production, Processing, and Handling of Food
- Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing: Administrative Procedures, Policies, and Requirements
- Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting-TriClip G4 System
- Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure Priority Review Voucher for QULIPTA
- Medical Imaging Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification for a New Dietary Ingredient
- Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure Priority Review Voucher; FABHALTA
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product
- Requests for Reconsideration at the Division Level Under the Generic Drug User Fee Amendments; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Records; Electronic Signatures
- Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin; International Council for Harmonisation; Guidance for Industry; Availability
- Filing of Color Additive Petition From Environmental Defense Fund, et al.; Request To Amend the Color Additive Regulations To Remove the Solvents Ethylene Dichloride, Methylene Chloride, and Trichloroethylene
- Filing of Food Additive Petition From Environmental Defense Fund, et al.; Request To Amend the Food Additive Regulations To Remove the Solvents Benzene, Ethylene Dichloride, Methylene Chloride, and Trichloroethylene
- Agency Information Collection Activities; Proposed Collection; Comment Request; Expedited Programs for Serious Conditions-Drugs and Biologics
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Extralabel Drug Use in Animals
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs
- Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product
- Food and Drug Administration's Draft Report and Plan on Best Practices for Guidance; Availability
Data: the U.S. Federal Register (Food and Drug Administration documents). Industry tags are a SPEQ keyword-derived interpretation, not official Federal Register metadata. Follow any entry for the authoritative document.