← ALL REGULATORY CHANGES
FDA Regulatory Changes — 2025 archive
Every record published in 2025 — 576 in total. Follow any entry for the decoded detail page.
December 2025
- Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products; Notice of Meeting; Establishment of a Public Docket; Request for Comments
- Over-the-Counter Monograph Drug User Fee Amendments-OTC Monograph Order Request Fee Rates for Fiscal Year 2026
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practices for Positron Emission Tomography Drugs
- Determination of Regulatory Review Period for Purposes of Patent Extension; ROMVIMZA
- Determination of Regulatory Review Period for Purposes of Patent Extension; ALHEMO
- Determination of Regulatory Review Period for Purposes of Patent Extension; ADZYNMA
- Determination of Regulatory Review Period for Purposes of Patent Extension; LEQEMBI
- Determination of Regulatory Review Period for Purposes of Patent Extension; OJEMDA
- Determination of Regulatory Review Period for Purposes of Patent Extension; ZELSUVMI
- Egis Pharmaceuticals Limited, et.al.; Proposal To Withdraw Approval of Three Abbreviated New Drug Applications; Opportunity for a Hearing
- Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices
- Authorization of Emergency Use for Two Animal Drugs for the Treatment of New World Screwworm; Availability
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance of Medical Devices
- Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
- Processes and Practices Applicable to Bioresearch Monitoring Inspections; Guidance for Industry; Availability
- Determination That EFFEXOR XR (Venlafaxine Hydrochloride) Extended-Release Capsule, 100 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product; FORZINITY (Elamipretide)
- Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph)
- Medical Devices; Neurological Devices; Classification of the Electrical Tongue Nerve Stimulator To Treat Motor Deficits
- Determination That DEXCHLORPHENIRAMINE MALEATE (Dexchlorpheniramine Maleate, Oral Syrup, 2 Milligrams/5 Milliliters) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Agency Information Collection Activities; Proposed Collection; Comment Request; Required Warnings for Cigarette Packages and Advertisements
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
- Questions and Answers Regarding Mandatory Cosmetics Recalls: Draft Guidance for Industry; Availability
- Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
- Investigator Responsibilities-Safety Reporting for Investigational Drugs and Devices; Guidance for Investigators, Industry, and Institutional Review Boards; Availability
- Sponsor Responsibilities-Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Bioequivalence Studies; Guidance for Industry; Availability
- Biosimilar User Fee Act; Stakeholder Consultation Meetings on Biosimilar User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate
- Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use
- Determination That ZANTAC (Ranitidine Hydrochloride) Injection, Equivalent to 25 Milligrams Base/Milliliter, Has Not Been Withdrawn From Sale for Reasons of Safety or Effectiveness
- Determination That LUNELLE (Estradiol Cypionate and Medroxyprogesterone Acetate) Injectable, 5 Milligrams/0.5 Milliliter and 25 Milligrams/0.5 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Determination That DEMEROL (Meperidine Hydrochloride) Tablet, 100 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Determination That BACTROBAN (Mupirocin) Nasal Ointment, 2%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Pfizer Inc., U.S. Agent for King Pharmaceuticals LLC, et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications
- Food and Drug Administration Expert Panel on Testosterone Replacement Therapy for Men; Request for Information
- Determination of Regulatory Review Period for Purposes of Patent Extension; FILSUVEZ
- Determination of Regulatory Review Period for Purposes of Patent Extension; GRAFAPEX
- Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Availability
- Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Standards Quality Act Requirements
- Agency Information Collection Activities; Proposed Collection; Comment Request; Establishment, Maintenance, and Availability of Records; Additional Traceability Records for Certain Foods
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Humanitarian Use Devices
- Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot
- Revocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability
- Product-Specific Guidance on Estradiol; Draft Guidance for Industry; Availability
- Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
- Medical Devices; Quality Management System Regulation Technical Amendments
- QTc Information in Human Prescription Drug and Biological Product Labeling; Guidance for Industry; Availability
- Monoclonal Antibodies: Streamlined Nonclinical Safety Studies; Draft Guidance for Industry; Availability
- Increasing Access to Nonprescription Drugs; Request for Information
- Medical Gases-Current Good Manufacturing Practice; Draft Guidance for Industry; Availability
- FDA's Strategy Document on Innovative Manufacturing Technologies
- Q3E Guideline for Extractables and Leachables; International Council for Harmonisation; Draft Guidance for Industry; Availability
November 2025
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Center for Devices and Radiological Health Appeals Processes
- Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products; Withdrawal
- Medical Devices; Gastroenterology-Urology Devices; Classification of the Anchored Esophageal Sheath
- Medical Devices; Neurological Devices; Classification of Field Generator Positioning Device
- Cross-Center Master Files: Where To Submit; Draft Guidance for Industry; Availability
- Green Innovation GmbH; Filing of Food Additive Petition (Animal Use)
- Immunology and Microbiology Devices; Reclassification of Nucleic Acid-Based Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product; Proposed Amendment; Proposed Order; Request for Comments
- Nicole Shelby Randall: Final Debarment Order
- Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments
- Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine; Public Workshop; Request for Comments
- Determination of Regulatory Review Period for Purposes of Patent Extension; ENVISION MAMMOGRAPHY PLATFORM
- Determination of Regulatory Review Period for Purposes of Patent Extension; ALTIUS DIRECT ELECTRICAL NERVE STIMULATION SYSTEM
- Intercept Pharmaceuticals, Inc., et al.; Withdrawal of Approval of New Drug Application for OCALIVA (Obeticholic Acid) Tablets, 5 Milligrams and 10 Milligrams, and Three Abbreviated New Drug Applications for Obeticholic Acid Tablets, 5 Milligrams and 10 Milligrams
- Tobacco Products Scientific Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emergency Use Authorization of Medical Products
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 510(k) Third-Party Review Program
- Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization
- Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
- General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice-Establishment of Public Docket; Request for Comments
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Small Dispensers Assessment Under the Drug Supply Chain Security Act
- Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies; Draft Guidance for Industry; Availability
- Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability
- Quality Management System Information for Certain Premarket Submission Reviews; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Menstrual Products-Performance Testing and Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers; Guidance for Industry; Availability
- Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use; Guidance for Industry; Availability
- Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-V-Wave Ventura Interatrial Shunt System
October 2025
- Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs With a New World Screwworm-Related Indication; Guidance for Industry; Availability
- Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 39 New Drug Applications; Correction
- Revocation of Emergency Use of a Biological Product; Availability
- Revocation of Emergency Use of Three Biological Products; Availability
- Pediatric Advisory Committee (PAC); Notice of Meeting; Establishment of a Public Docket; Request for Comments
- Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
- Jason Oppenheimer: Final Debarment Order
- Yong Sheng Jiao: Denial of Application for Termination of Debarment
- Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue; Confirmation of Effective Date
September 2025
- E20 Adaptive Designs for Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; Availability
- Determination of Regulatory Review Period for Purposes of Patent Extension; DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE
- Determination of Regulatory Review Period for Purposes of Patent Extension; TRICLIP
- Determination of Regulatory Review Period for Purposes of Patent Extension; MIPLYFFA
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United States
- Determination of Regulatory Review Period for Purposes of Patent Extension; NIKTIMVO
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mitigation Strategies To Protect Food Against Intentional Adulteration
- Determination That SEMPREX-D (Acrivastine and Pseudoephedrine Hydrochloride) Capsules, 8 Milligrams and 60 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and Issue Certifications
- Revocation of Food Standards for 11 Products Not Currently Sold; Confirmation of Effective Date
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Agreement for Shipment of Devices for Sterilization
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Sanitary Transportation of Human and Animal Food
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Prohibited From Use in Animal Food or Feed
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Food Facilities
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Production, Storage, and Transportation of Shell Eggs (Preventing Salmonella Enteritidis)
- Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices for Positron Emission Tomography Drugs
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
- Postapproval Methods To Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Draft Guidance for Industry; Availability
- Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations; Draft Guidance for Industry; Availability
- Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry; Availability
- Prior Notice: Adding Requirement To Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe for Post-Refusal and Post-Hold Submissions
- Elite Laboratories, Inc., et al.; Withdrawal of Approval of 72 Abbreviated New Drug Applications
- Computer Software Assurance for Production and Quality System Software; Guidance for Industry and Food and Drug Administration Staff; Availability
- ADUFA V Third-Party Assessment Report: Notice of Availability; Virtual Public Meeting; Request for Comments
- Approval of Previously Withdrawn New Drug Application for WELLCOVORIN (Leucovorin Calcium) Tablets
- Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency; Guidance for Industry and Food and Drug Administration Staff; Availability
- Malaria: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
- Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development-Leveraging Rare Disease Frameworks; Public Meeting
- Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
- Ultra-Processed Foods; Request for Information; Extension of Comment Period
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request, Exemptions From Substantial Equivalence Requirements for Tobacco Products
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Meetings With Industry and Investigators on the Research and Development of Tobacco Products
- Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Southern Hemisphere Influenza Virus Vaccines; Center for Biologics Evaluation and Research (CBER) Allergen Standardization Program
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Health Document Submission
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Considerations
- William Goldsmith: 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; Correction
- Regulation Identification Number 0910-AJ05 Medical Devices; Laboratory Developed Tests; Implementation of Vacatur
- Fee Rate for Using a Priority Review Voucher in Fiscal Year 2026
- Radiological Health Regulations; Technical Amendments
- Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices
- Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
- Erosive Esophagitis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
- Disseminated Coccidioidomycosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
- Proposal To Remove the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausages
- Digital Health Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Generative Artificial Intelligence-Enabled Digital Mental Health Medical Devices
- Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications; Guidance for Industry; Availability
- Development of Non-Opioid Analgesics for Chronic Pain, Draft Guidance for Industry; Availability
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Product Establishment Registration and Listing
- Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations; Guidance for Industry; Availability
- Classification Categories for Certain Supplements Under Biosimilar User Fee Amendments III; Guidance for Industry; Availability
- M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver; International Council for Harmonisation; Draft Guidance for Industry; Reopening of the Comment Period
- E6(R3) Good Clinical Practice; International Council for Harmonisation; Guidance for Industry; Availability
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Manufactured Food Regulatory Program Standards
- Bausch & Lomb Incorporated, et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications; Correction
- Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 in Yogurt and Other Cultured Dairy Products Fermented With Lactobacillus delbrueckii, Subspecies bulgaricus, and Streptococcus thermophilus
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; FDA Food Safety and Nutrition Survey
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices; Foreign Letters of Approval
- General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Accessories
- Biomin GmbH; Filing of Food Additive Petition (Animal Use)
- Determination That NUTRACORT (Hydrocortisone) Topical Gel, 1%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Secondary Direct Food Additives Permitted in Food for Human Consumption; Hydrogen Peroxide
August 2025
- Advisory Committee; Arthritis Advisory Committee; Termination; Removal From List of Standing Committees
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Submissions of Medical Device Registration and Listing
- Amylyx Pharmaceuticals, Inc.; Withdrawal of Approval of New Drug Application for RELYVRIO (Sodium Phenylbutyrate and Taurursodiol) for Suspension, 3 Gram/Packet and 1 Gram/Packet
- Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement
- Patient-Focused Drug Development: Workshop #2 To Discuss Methodologic and Other Challenges Related to Patient Experience Data; Public Workshop; Request for Comments
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product; MODESYO (dordaviprone)
- Determination of Regulatory Review Period for Purposes of Patent Extension; IQIRVO
- Determination of Regulatory Review Period for Purposes of Patent Extension; LUMISIGHT
- Determination of Regulatory Review Period for Purposes of Patent Extension; NEMLUVIO
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Generally Recognized as Safe (GRAS): Notifications and Convening Panels
- Determination of Regulatory Review Period for Purposes of Patent Extension; YORVIPATH
- Determination of Regulatory Review Period for Purposes of Patent Extension; ZUNVEYL
- Determination of Regulatory Review Period for Purposes of Patent Extension; VORANIGO
- Determination of Regulatory Review Period for Purposes of Patent Extension; OHTUVAYRE
- Determination of Regulatory Review Period for Purposes of Patent Extension; CAMZYOS
- Determination of Regulatory Review Period for Purposes of Patent Extension; PIASKY
- Determination of Regulatory Review Period for Purposes of Patent Extension; SOFDRA
- Determination That Four Heparin Sodium In Sodium Chloride In Plastic Container (Heparin Sodium) Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment; Public Meeting; Request for Comments
- Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Food and Egg Regulatory Program Standards
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Reagents for Detection of Specific Novel Influenza A Viruses
- Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records
- Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents
- Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Retailer Training Programs
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishing and Maintaining Lists of United States Establishments With Interest in Exporting Human Food Program-Regulated Products
- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
- Animal Studies for Dental Bone Grafting Material Devices-Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
- 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
- Medical Devices; Immunology and Microbiology Devices; Classification of the Device That Detects Nucleic Acid Sequences From Microorganisms Associated With Vaginitis and Bacterial Vaginosis
- Medical Devices; Immunology and Microbiology Devices; Classification of the Anti-Phospholipase A2 Receptor Immunological Test System
- Medical Devices; Immunology and Microbiology Devices; Classification of the Postnatal Chromosomal Copy Number Variation Detection System
- Medical Devices; Radiology Devices; Classification of the Liver Iron Concentration Imaging Companion Diagnostic for Deferasirox
- Medical Devices; Immunology and Microbiology Devices; Classification of A Multiplex Respiratory Panel To Detect and Identify Emerging Respiratory Pathogen(s) and Common Respiratory Pathogens in Human Clinical Specimens
- Medical Devices; Immunology and Microbiology Devices; Classification of the Cancer Predisposition Risk Assessment System
- Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Menopause Test System
- Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Pharmacogenetic Assessment System
- Medical Devices; Immunology and Microbiology Devices; Classification of the Mutation Detection Test for Myeloproliferative Neoplasms
- Medical Devices; Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use With Total Disc Replacement Devices
- Medical Devices; Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use With Non-Fusion Spinous Process Spacer Devices
- Medical Devices; Gastroenterology-Urology Devices; Classification of the Laparoscopic Gastrointestinal Sizing Tool
- Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract; Confirmation of Effective Date
- Listing of Color Additives Exempt From Certification; Galdieria Extract Blue; Confirmation of Effective Date
- Listing of Color Additives Exempt From Certification; Calcium Phosphate; Confirmation of Effective Date
- Determination That RIFADIN (Rifampin) Capsules, 150 Milligrams and 300 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Doyal Kalita: Final Debarment Order
- Evonik Corporation; Filing of Food Additive Petition (Animal Use)
- Approaches to Assessment of Overall Survival in Oncology Clinical Trials; Draft Guidance for Industry; Availability
- Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development; Draft Guidance for Industry; Availability
- Lessons Learned From the Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Public Workshop; Request for Comments
- Revocation of Authorization of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
- Biosimilar User Fee Act III Regulatory Science Program Interim Public Meeting; Public Meeting; Interim Report; Availability; Request for Comments
- Advancing the Development of Interchangeable Products: Identifying Future Needs; Public Workshop; Request for Comments
- Food Standards of Identity Modernization; Pasteurized Orange Juice; Proposed Rule; Correction
- Product-Specific Guidance on Iron Sucrose; Draft Guidance for Industry; Availability
- Onshoring Manufacturing of Drugs and Biological Products; Public Meeting; Request for Comments
- Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Humanitarian Use Devices
- Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products
- Agency Information Collection Activities; Proposed Collection; Comment Request; Collection of Conflict-of-Interest Information for Participation in Food and Drug Administration Non-Employee Fellowship and Traineeship Programs
- Requirements for Additional Traceability Records for Certain Foods: Compliance Date Extension
- Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue; Correction
- Food Standards of Identity Modernization; Pasteurized Orange Juice
- Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction
- Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 39 New Drug Applications
- Prescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application Review; Final Report; Availability; Reopening of Comment Period
- Determination That HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (Heparin Sodium) Injectable, 200 Units/100 Milliliters, and Two Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Determination That ROXICET (Oxycodone Hydrochloride and Acetaminophen) Tablet, 5 Milligrams and 325 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
July 2025
- Medical Device User Fee Small Business Qualification and Determination Guidance Final Guidance for Industry and Food and Drug Administration Staff and Foreign Governments; Availability
- Arthritis Advisory Committee; Termination
- General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice-Establishment of Public Docket; Request for Comments-Dermal Fillers
- Tobacco Products Scientific Advisory Committee; Notice of Meeting
- Food Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2026
- Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2026
- Outsourcing Facility Fee Rates for Fiscal Year 2026
- Generic Drug User Fee Rates for Fiscal Year 2026
- Medical Device User Fee Rates for Fiscal Year 2026
- Prescription Drug User Fee Rates for Fiscal Year 2026
- Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2026
- Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2026
- Biosimilar User Fee Rates for Fiscal Year 2026
- Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2026
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Notification Procedures for Statements of Dietary Supplements
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tropical Disease Priority Review Vouchers
- 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; Compounding Animal Drugs From Bulk Drug Substances
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export Notification and Recordkeeping Requirements
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Reporting
- Revocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability
- APIX Biosciences US LLC; Filing of Food Additive Petition (Animal Use)
- Spoonbill Foundation; Filing of Food Additive Petition
- Regulatory Hearing Before the Food and Drug Administration
- Ultra-Processed Foods; Request for Information
- E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; Availability
- Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products; Guidance for Industry; Availability
- Development of Cancer Drugs for Use in Novel Combination-Determining the Contribution of the Individual Drugs' Effects; Draft Guidance for Industry; Availability
- Proposal To Revoke 23 Standards of Identity for Foods
- Revocation of Food Standards for 11 Products Not Currently Sold
- Revocation of Food Standards for 11 Products Not Currently Sold
- Proposal To Revoke 18 Standards of Identity for Dairy Products
- Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen; Draft Guidance for Industry; Availability
- Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue
- Determination of Regulatory Review Period for Purposes of Patent Extension; IMDELLTRA
- Determination of Regulatory Review Period for Purposes of Patent Extension; KISUNLA
- Determination of Regulatory Review Period for Purposes of Patent Extension; ABRYSVO
- Agency Information Collection Activities; Proposed Collection; Comment Request; The Real Cost Campaign Outcomes Evaluation Study: Cohort 3
- Determination of Regulatory Review Period for Purposes of Patent Extension; HEMGENIX
- Agency Information Collection Activities; Proposed Collection; Comment Request; Emergency Use Authorization of Medical Products
- Agency Information Collection Activities; Proposed Collection; Comment Request; Q-Submission and Early Payor Feedback Request Programs and Medical Device Development Tools
- Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Products
- Determination of Regulatory Review Period for Purposes of Patent Extension; LAZCLUZE
- Determination of Regulatory Review Period for Purposes of Patent Extension; TECELRA
- Agency Information Collection Activities; Proposed Collection; Comment Request; Certification of Identity for Freedom of Information Act and Privacy Act Requests
- Request for Nominations for Voting Members on the Tobacco Products Scientific Advisory Committee
- Agency Information Collection Activities; Proposed Collection; Comment Request; Meetings With Industry and Investigators on the Research and Development of Tobacco Products
- Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations; Draft Guidance for Industry; Availability
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
- Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization
- Agency Information Collection Activities; Proposed Collection; Comment Request; Warning Plans for Certain Tobacco Products
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
- Agency Information Collection Activities; Proposed Collection; Comment Request; 510(k) Third-Party Review Program
- Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Quick Turnaround Testing of Communication Effectiveness
- Agency Information Collection Activities; Proposed Collection; Comment Request; Emerging Drug Safety Technology Meeting Program
- Agency Information Collection Activities; Proposed Collection; Comment Request; Center for Devices and Radiological Health Appeals Processes
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; The Real Cost Monthly Implementation Assessment
- General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of Public Docket; Request for Comments-Dermal Fillers
- Determination That SYNDROS (Dronabinol) Solution, 5 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Myelodysplastic Syndromes: Developing Drug and Biological Products for Treatment; Draft Guidance for Industry; Availability
- Agency Information Collection Activities; Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization
- Agency Information Collection Activities; Proposed Collection; Comment Request; Environmental Impact Considerations
- Agency Information Collection Activities; Proposed Collection; Comment Request; Mitigation Strategies To Protect Food Against Intentional Adulteration
- Determination of Regulatory Review Period for Purposes of Patent Extension; [TOTAL POSTERIOR SPINE SYSTEM (TOPS SYSTEM)]
- Determination of Regulatory Review Period for Purposes of Patent Extension; [CHOCOLATE TOUCH (PACLITAXEL DRUG COATED PTA BALLOON CATHETER)]
- Determination of Regulatory Review Period for Purposes of Patent Extension; WINREVAIR
- Determination of Regulatory Review Period for Purposes of Patent Extension; REBYOTA
- Determination of Regulatory Review Period for Purposes of Patent Extension; ELREXFIO; Correction
- Determination of Regulatory Review Period for Purposes of Patent Extension; LIVDELZI
June 2025
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
- Medical Device User Fee Amendments; Stakeholder Meetings on the Medical Device User Fee Amendments of Fiscal Years 2028 to 2032 Reauthorization; Request for Notification of Stakeholder Intention To Participate
- Change in Federal Payment and Collection Options
- Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases-Questions and Answers; Guidance for Industry; Availability
- June 27, 2025-Agency Information Collection Activities; Proposed Collection; Comment Request; Meetings With Industry and Investigators on the Research and Development of Tobacco Products
- Agency Information Collection Activities; Proposed Collection; Comment Request; Production, Storage, and Transportation of Shell Eggs (Preventing Salmonella Enteritidis)
- Agency Information Collection Activities; Proposed Collection; Comment Request; Exemptions From Substantial Equivalence Requirements for Tobacco Products
- Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities
- Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Health Document Submission
- Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
- Agency Information Collection Activities; Proposed Collection; Comment Request; Sanitary Transportation of Human and Animal Food
- Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act
- Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Generally Recognized as Safe: Notifications and Convening Panels
- Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007
- Agency Information Collection Activities; Proposed Collection; Comment Request; Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and Issue Certifications
- Conducting Remote Regulatory Assessments-Questions and Answers; Guidance for Industry; Availability
- Generic Drug User Fees; Consultation Meetings on Reauthorization of Generic Drug User Fee Amendments for Fiscal Years 2028-2032; Request for Notification of Intention to Participate
- Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Lysosomal Storage Disorder Newborn Screening Test System
- Medical Devices; Radiology Devices; Classification of the Cream for X-Ray Attenuation
- Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 064
- Medical Devices; Hematology and Pathology Devices; Classification of the Fluorescence In Situ Hybridization-Based Detection of Chromosomal Abnormalities From Patients With Hematologic Malignancies
- Medical Devices; Immunology and Microbiology Devices; Classification of the Herpes Simplex Virus Nucleic Acid-Based Assay for Central Nervous System Infections
- Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Muscular Dystrophy Newborn Screening Test
- Unique Device Identifier Requirements for Combination Products; Draft Guidance for Industry and FDA Staff; Availability
- Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment; Guidance for Industry; Availability
- Revocation of Authorization of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
- Request for Nominations for Voting Members on the Tobacco Products Scientific Advisory Committee
- Determination of Regulatory Review Period for Purposes of Patent Extension; [EDWARDS SAPIEN 3 TRANSCATHETER PULMONARY VALVE]
- Determination of Regulatory Review Period for Purposes of Patent Extension; AGAMREE
- Determination of Regulatory Review Period for Purposes of Patent Extension; [EDWARDS SAPIEN 3 ULTRA RESILIA-PMA 140031 S-141]
- Determination of Regulatory Review Period for Purposes of Patent Extension; FILSPARI
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration's Adverse Event and Product Experience Reporting Program
- Q1 Stability Testing of Drug Substances and Drug Products; International Council for Harmonisation; Draft Guidance for Industry; Availability
- Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submissions of Medical Device Registration and Listing
- Determination of Regulatory Review Period for Purposes of Patent Extension; TALVEY
- Determination of Regulatory Review Period for Purposes of Patent Extension; ZILBRYSQ
- Determination of Regulatory Review Period for Purposes of Patent Extension; QALSODY
- Determination of Regulatory Review Period for Purposes of Patent Extension; VELSIPITY
- Determination of Regulatory Review Period for Purposes of Patent Extension; ALTUVIIIO
- Determination of Regulatory Review Period for Purposes of Patent Extension; JOENJA
- Determination of Regulatory Review Period for Purposes of Patent Extension; EXEM FOAM
- Determination of Regulatory Review Period for Purposes of Patent Extension; TRUQAP
- Determination of Regulatory Review Period for Purposes of Patent Extension; COLUMVI
- Determination of Regulatory Review Period for Purposes of Patent Extension; BREYANZI
- Post-Warning Letter Meetings Under Generic Drug User Fee Amendments; Guidance for Industry; Availability
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Interstate Shellfish Dealer's Certificate and Participation in the National Shellfish Sanitation Program
- Modified Risk Tobacco Product Application: Applications for ZYN Products Submitted by Swedish Match U.S.A., Inc.
- Medical Devices; Exemptions From Premarket Notification: Class II Devices; Clinical Electronic Thermometers
- Yogurt Products Deviating From Standard of Identity; Temporary Permit for Market Testing
- Cheese Products Deviating From Standard of Identity; Temporary Permit for Market Testing
- Psychopharmacologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Supplemental New Drug Application (sNDA) 205422/S-012 for REXULTI (brexpiprazole) Tablets
- Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologic License Application (BLA) 761440 for Belantamab Mafodotin
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drug and Veterinary Master Files
- Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance of Medical Devices
- Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Accessories
- Agency Information Collection Activities; Proposed Collection; Comment Request; Abbreviated New Animal Drug Applications
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Detention and Banned Medical Devices
- Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Medical Devices; Foreign Letters of Approval
- Agency Information Collection Activities; Proposed Collection; Comment Request; Manufactured Food Regulatory Program Standards
- Abbreviated New Drug Applications: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions; Guidance for Industry; Availability
- Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population; Public Meeting; Establishment of a Public Docket; Request for Comments
- Determination of Regulatory Review Period for Purposes of Patent Extension; BRIUMVI
- Determination of Regulatory Review Period for Purposes of Patent Extension; POMBILITI
- Determination of Regulatory Review Period for Purposes of Patent Extension; [IMPELLA RP FLEX WITH SMART ASSIST]
- Determination of Regulatory Review Period for Purposes of Patent Extension; [AVEIR VR LEADLESS SYSTEM]
- Determination of Regulatory Review Period for Purposes of Patent Extension; XOLREMDI
- Determination of Regulatory Review Period for Purposes of Patent Extension; VOYDEYA
- Determination of Regulatory Review Period for Purposes of Patent Extension; VAFSEO
- Determination of Regulatory Review Period for Purposes of Patent Extension; [NAVITOR TRANSCATHETER AORTIC VALVE IMPLANT]
- Determination of Regulatory Review Period for Purposes of Patent Extension; ZEVTERA
- Determination of Regulatory Review Period for Purposes of Patent Extension; VOWST
- Determination of Regulatory Review Period for Purposes of Patent Extension; RIVFLOZA
- Determination of Regulatory Review Period for Purposes of Patent Extension; ROLVEDON
- Determination of Regulatory Review Period for Purposes of Patent Extension; BEYFORTUS
- Pediatric Advisory Committee (PAC); Notice of Meeting; Establishment of a Public Docket; Request for Comments
- Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
- Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Fungal Nucleic Acids Directly in Respiratory Specimens
- Medical Devices; Immunology and Microbiology Devices; Classification of the Cellular Analysis System for Multiplexed Antimicrobial Susceptibility Testing
- Medical Devices; Immunology and Microbiology Devices; Classification of the Clinical Mass Spectrometry Microorganism Identification and Differentiation System
- Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Detection and Diagnosis Software
- Rare Disease Innovation, Science, and Exploration Public Workshop Series; Request for Comments
- Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product
- Reauthorization of the Medical Device User Fee Amendments; Public Meeting; Request for Comments
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Small Business Qualification and Certification
- Hernia Mesh-Package Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol; International Council for Harmonisation; Draft Technical Specification; and Template; Availability
- Transfer of a Premarket Notification (510(k)) Clearance-Questions and Answers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs; Draft Guidance for Industry; Availability
- Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs
- Over-the-Counter Monograph Condition B001: Single-Unit or Unit-Dose Containers for Over-the-Counter Monograph Drugs in Orally Disintegrating Tablet and Film Dosage Forms
- Raw Data for Safety and Effectiveness Studies; Guidance for Industry; Availability
- Medical Devices; Radiology Devices; Classification of the Radiological Acquisition and/or Optimization Guidance System
- Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect Bacterial Protease Activity in Chronic Wound Fluid
- M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver; International Council for Harmonisation; Draft Guidance for Industry; Availability
- Determination That EPINEPHRINE (Epinephrine) Solution, 1 Milligram/Milliliter, Prefilled Syringe for Intravenous Use, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
May 2025
- Determination of Regulatory Review Period for Purposes of Patent Extension; LOQTORZI
- Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability
- Determination That COREG CR (Carvedilol Phosphate) Extended-Release Capsules, 10 Milligrams, 20 Milligrams, 40 Milligrams, and 80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Mullerian Hormone Test System
- Determination That ACTIGALL (Ursodiol) Capsule, 150 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Meda AB and B. Braun Medical, Inc.; Withdrawal of Approval of Two New Drug Applications
- Evan Asher Field: Final Debarment Order
- Replacing Color Additives in Approved or Marketed Drug Products; Draft Guidance for Industry; Availability
- Second Annual Animal Drug User Fee Educational Conference; Public Meeting
- Electronic Submission Template for Medical Device Q-Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Guidance for Industry and Food and Drug Administration Staff; Availability
- Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Plazomicin Test System
- Medical Devices; Immunology and Microbiology Devices; Classification of the Zika Virus Serological Reagents
- Medical Devices; Gastroenterology-Urology Devices; Classification of the Temporarily-Placed Urethral Opening System for Symptoms of Benign Prostatic Hyperplasia
- Medical Devices; Immunology and Microbiology Devices; Classification of the Inherited Nucleotide Repeat Disorder Deoxyribonucleic Acid Test
- Justin Cole Henry: Final Debarment Order
- Michael Dominic Diaz: Final Debarment Order
- Carlton Reico Mallard Jr.: Final Debarment Order
- Quality Poultry and Seafood, Incorporated: Final Debarment Order
- Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event: Draft Guidance for Industry; Reopening of Comment Period
- Revocation of Four Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
- Listing of Color Additives; Myoglobin; Confirmation of Effective Date
- Growing, Harvesting, Processing, and Distribution of Poppy Seeds-Industry Practices Related to Opiate Alkaloids; Request for Information; Extension of Comment Period; Correction
- Revocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability
- Product-Specific Guidance on Fluticasone Propionate; Draft Guidance for Industry; Availability
- Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
- Product-Specific Guidance on Roflumilast; Draft Guidance for Industry; Availability
- Dihydropyrimidine Dehydrogenase Deficiency and the Use of Fluoropyrimidine Chemotherapy Drugs; Establishment of a Public Docket; Request for Comments
- Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments
- Determination of Regulatory Review Period for Purposes of Patent Extension; ELAHERE
- Food Additives Permitted in Feed and Drinking Water of Animals; Selenium
- Reauthorization of the Generic Drug User Fee Amendments; Public Meeting; Request for Comments
- Infant Formula Nutrient Requirements; Request for Information
- Determination of Regulatory Review Period for Purposes of Patent Extension; OMVOH
- Determination of Regulatory Review Period for Purposes of Patent Extension; SKINVIVE
- Determination of Regulatory Review Period for Purposes of Patent Extension; EPKINLY
- Determination of Regulatory Review Period for Purposes of Patent Extension; ADBRY
- Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract
- Listing of Color Additives Exempt From Certification; Calcium Phosphate
- Listing of Color Additives Exempt From Certification; Galdieria Extract Blue
- Determination of Regulatory Review Period for Purposes of Patent Extension; SKYCLARYS
- Determination of Regulatory Review Period for Purposes of Patent Extension; JAYPIRCA
- Determination of Regulatory Review Period for Purposes of Patent Extension; LITFULO
- Determination of Regulatory Review Period for Purposes of Patent Extension; ELREXFIO
- Determination of Regulatory Review Period for Purposes of Patent Extension; NGENLA
- Determination of Regulatory Review Period for Purposes of Patent Extension; SUNLENCA
- Determination of Regulatory Review Period for Purposes of Patent Extension; LAMZEDE
- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor
- Medical Devices; Immunology and Microbiology Devices; Classification of the DNA-Based Test To Measure Minimal Residual Disease in Hematological Malignancies
- Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Measure Non-Microbial Analytes To Aid in the Detection and Identification of Localized Human Infections
- Medical Devices; Immunology and Microbiology Devices; Classification of the Microbial Nucleic Acid Storage and Stabilization Device
- Medical Devices; Immunology and Microbiology Devices; Classification of the Cytomegalovirus Nucleic Acid Detection Device for Congenital Cytomegalovirus Infection
- Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Breast Milk Macronutrients Test System
- Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Voriconazole Test System
- Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect Nucleic Acids From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections and Associated Resistance Marker(s)
- Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Nucleic Acids by Fluorescence In Situ Hybridization in Clinical Specimens
- Medical Devices; Hematology and Pathology Devices; Classification of the Coagulation System for the Measurement of Whole Blood Viscoelastic Properties in Perioperative Patients
- Food Labeling: Front-of-Package Nutrition Information; Extension of Comment Period
- Determination That VOSOL (Acetic Acid, Glacial) 2% Otic Solution/Drops; and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Prescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application Review; Final Report; Availability; Request for Comments
- Prescription Drug User Fee Act; Stakeholder Consultation Meetings on the Prescription Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate
- Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Supplemental Biologics License Application 761309/S-001, for COLUMVI (glofitamab) Injection; Supplemental Biologics License Application 761145/S-029, for DARZALEX FASPRO (daratumumab and hyaluronidase) Injection; New Drug Application 215793, for (mitomycin) Intravesical Solution; Supplemental New Drug Application 211651/S-013, for TALZENNA (talazoparib) Capsules
- Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-2025-2026 Formula for COVID-19 Vaccines for Use in the United States
- Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting
- Recommendations To Reduce the Risk of Transmission of Disease Agents Associated With Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products; Recommendations To Reduce the Risk of Transmission of Mycobacterium Tuberculosis by Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidances for Industry; Availability
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Drug User Fee Program
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Microbiological Testing and Corrective Measures for Bottled Water
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities
- Agency Information Collection Activities; Proposed Collection; Comment Request; Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pharmaceutical Distribution Supply Chain; Drug Supply Chain Security
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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; Prescription Drug User Fee Program
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Financial Disclosure by Clinical Investigators
- Agency Information Collection Activities; Proposed Collection; Comment Request; Compounding Animal Drugs From Bulk Drug Substances
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medicated Feed Mill License Application
- Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Antimicrobial Animal Drug Sales and Distribution
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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; Tropical Disease Priority Review Vouchers
- Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Reagents for Detection of Specific Novel Influenza A Viruses
- Agency Information Collection Activities; Proposed Collection; Comment Request; Establishing and Maintaining Lists of United States Establishments With Interest in Exporting Human Food Program-Regulated Products
- Agency Information Collection Activities; Proposed Collection; Comment Request; Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
- Agency Information Collection Activities; Proposed Collection; Comment Request; Export Notification and Recordkeeping Requirements
April 2025
- Exploration of Health Level Seven Fast Healthcare Interoperability Resources for Use in Study Data Created From Real-World Data Sources for Submission to the Food and Drug Administration; Establishment of a Public Docket; Request for Comments
- Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program
- Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure Priority Review Voucher; EYLEA HD (aflibercept)
- Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product; EBANGA
- Determination That MOBIC (Meloxicam) Tablets, 7.5 Milligrams and 15 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; TREMFYA (guselkumab)
- Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; AMVUTTRA (vutrisiran)
- Action Levels for Lead in Processed Food Intended for Babies and Young Children; Guidance for Industry; Availability; Correction
- Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Amendment of Notice-Extended-Release/Long-Acting Opioid Analgesic Postmarketing Requirement
- Determination That NASCOBAL (Cyanocobalamin) Nasal Spray, 0.5 Milligram/Spray, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Determination That ETHYOL (Amifostine) for Injection, 500 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- GE HealthCare, et al.; Withdrawal of Approval of 18 New Drug Applications
- Determination That DECADRON (Dexamethasone Sodium Phosphate) Solution/Drops, Equivalent to 0.1 Percent Phosphate, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Type VII Veterinary Master File for Research and Development and Risk Reviews; Draft Guidance for Industry; Reopening of the Comment Period
- 21st Century Cures Act: Annual Compilation of Notices of Updates From the Susceptibility Test Interpretive Criteria Web Page; Request for Comments
- Growing, Harvesting, Processing, and Distribution of Poppy Seeds-Industry Practices Related to Opiate Alkaloids; Request for Information; Extension of Comment Period
- Determination That FLUMADINE (Rimantadine Hydrochloride) Tablet, 100 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Electronic Study Data Submission; Data Standards; Clinical Data Interchange Standards Consortium Dataset-JavaScript Object Notation; Request for Comments
- Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction
- Determination That VIBRAMYCIN (Doxycycline) for Oral Suspension, Equivalent 25 Milligrams Base/5 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
March 2025
- Nonprescription Drug Product With an Additional Condition for Nonprescription Use
- Over-the-Counter Monograph Drug User Fee Program-Facility Fee Rates for Fiscal Year 2025
- Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
- Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 063
- Impossible Foods, Inc.; Filing of Color Additive Petition
- Sage Therapeutics, Inc.; Withdrawal of Approval of a New Drug Application for ZULRESSO (Brexanolone) Solution, 100 Milligrams/20 Milliliters
- Bausch & Lomb Incorporated, et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications
- Bausch & Lomb Incorporated, et al.; Withdrawal of Approval of Four Abbreviated New Drug Applications
- Bernardo Garmendia; Denial of Hearing; Final Debarment Order
- Determination That RIOMET (Metformin Hydrochloride) Oral Solution, 500 Milligrams/5 Milliliters Has Not Been Withdrawn From Sale for Reasons of Safety or Effectiveness
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product; Gomekli (mirdametinib)
- E6(R3) Good Clinical Practice: Annex 2; International Council for Harmonisation; Draft Guidance for Industry; Reopening of the Comment Period
- Harpreet Singh: Final Debarment Order
- Alnashir Alibhai Punjani: Final Debarment Order
- Jonathan Corbett Cosie: Final Debarment Order
- John Warrington Kosolcharoen: Final Debarment Order
- Notice of the Denial of a Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon)
February 2025
- Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biosimilars User Fee Program
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Labeling Requirements for Prescription Drugs
- Guidance for Industry; Recommendations To Reduce the Risk of Transmission of Disease Agents Associated With Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products; Recommendations To Reduce the Risk of Transmission of Mycobacterium Tuberculosis by Human Cells, Tissues, and Cellular and Tissue-Based Products
January 2025
- Nonprescription Drug Product With an Additional Condition for Nonprescription Use
- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
- Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments; Withdrawal
- Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration's Adverse Event and Product Experience Reporting Program
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Experience Reporting
- Agency Information Collection Activities; Proposed Collection; Improving the Quality and Representativeness of the Treatment Center Program Data-Data Modifications to the Current Survey Instrument Format to Minimize Misclassification; Withdrawal of Notice
- Optimizing Pregnancy Registries; Public Workshop
- Expedited Program for Serious Conditions-Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Extension of Comment Period
- Use of a Type V Drug Master File for Model Master File Submissions To Support Abbreviated New Drug Applications; Establishment of a Public Docket; Request for Comments
- Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in Oncology; Draft Guidance for Industry; Availability
- Cell Therapies and Tissue-Based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development; Public Workshop; Request for Comments
- Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Product Establishment Registration and Listing
- Listing of Color Additives Exempt From Certification; Myoglobin
- Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products
- Food Labeling: Front-of-Package Nutrition Information
- Color Additive Petition From Center for Science in the Public Interest, et al.; Request To Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs
- Use of Cannabis-Derived Products, Including Cannabidiol, in Veterinary Practice; Request for Information
- Proposal to Refuse to Approve a New Drug Application for TRADIPITANT; Opportunity for a Hearing
- Recommendations To Reduce the Risk of Transfusion-Transmitted Malaria; Draft Guidance for Industry; Availability
- Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications
- Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 12 New Drug Applications
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ALHEMO (concizumab-mtci)
- High-Protein Yogurt; Request for Information
- Growing, Harvesting, Processing, and Distribution of Poppy Seeds-Industry Practices Related to Opiate Alkaloids; Request for Information
- Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Drug User Fee Program
- Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product; CRENESSITY (crinecerfont)
- Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; ALYFTREK (vanzacaftor, tezacaftor, and deutivacaftor)
- National Antimicrobial Resistance Monitoring System 2026-2030 Strategic Plan; Request for Comments
- Advisory Committee; Antimicrobial Drugs Advisory Committee; Renewal
- Withdrawal of Food and Drug Administration Notice Regarding Yong Sheng Jiao; Denial of Hearing; Final Debarment Order
- Yong Sheng Jiao; Denial of Hearing; Final Debarment Order
- Developing Drugs for Optical Imaging; Draft Guidance for Industry; Availability
- Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction; Draft Guidance for Industry; Availability
- Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Draft Guidances Relating to Recommendations To Reduce the Risk of Transmission of Relevant Communicable Disease Agents and Diseases by Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidances for Industry; Availability
- Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability
- Food and Drug Administration Animal Food Ingredient Consultation; Guidance for Industry; Availability
- Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway; Draft Guidance for Industry; Availability
- Establishing Sanitation Programs for Low-Moisture Ready-To-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event; Draft Guidance for Industry; Availability
- Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act; Guidance for FDA Staff and Interested Parties; Availability
- Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease; Draft Guidance for Industry; Availability
- Type VII Veterinary Master File for Research and Development and Risk Reviews; Draft Guidance for Industry; Availability
- Heritable Intentional Genomic Alterations in Animals: The Approval Process; Guidance for Industry; Availability
- Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry; Availability
- Action Levels for Lead in Processed Food Intended for Babies and Young Children; Guidance for Industry; Availability
- Labeling of Plant-Based Alternatives to Animal-Derived Foods: Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
- Considerations for Including Tissue Biopsies in Clinical Trials; Draft Guidance for Industry, Investigators, Institutions, and Institutional Review Boards; Availability
- Study of Sex Differences in the Clinical Evaluation of Medical Products; Draft Guidance for Industry; Availability
- Recommendations To Reduce the Risk of Transmission of Disease Agents Associated With Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability
- Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers; Guidance for Industry; Availability; Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request
- Pulse Oximeters for Medical Purposes-Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Validation and Verification of Analytical Testing Methods Used for Tobacco Products; Guidance for Industry; Availability
- Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability; Comment Request
- Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Recommendations To Reduce the Risk of Transmission of Mycobacterium Tuberculosis by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability
- Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
- Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
- Notifying the Food and Drug Administration of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry and Food and Drug Administration Staff; Availability
- Considerations for Complying With 21 CFR 211.110; Draft Guidance for Industry; Availability
- Food Contact Notifications That Are No Longer Effective
- Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee
- Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act
- Liquid Eggs Deviating From the Standard of Identity; Revocation of Temporary Permit for Market Testing
- Advanced Manufacturing Technologies Designation Program; Guidance for Industry; 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.