← ALL REGULATORY CHANGES
FDA Regulatory Changes — 2026 archive
Every record published in 2026 — 510 in total. Follow any entry for the decoded detail page.
September 2026
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed
- Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Tracking
- Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acid (PABA) and Trolamine Salicylate
- Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software
- Medical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device
- Medical Devices; Radiology Devices; Classification of the Vaginal Hydrogel Packing System
- Medical Devices; Gastroenterology-Urology Devices; Classification of the Implanted Tibial Electrical Urinary Continence Device
- Medical Devices; Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT Surgery
- Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Test System for Inflammatory Bowel Disease
- Medical Devices; Cardiovascular Devices; Classification of the Extravascular Support for an Arteriovenous Fistula for Vascular Access
- Medical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures
- Medical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation Procedures
- Fee Rate for Using a Priority Review Voucher in Fiscal Year 2027
- Green Innovation GmbH; Withdrawal of Food Additive Petition (Animal Use)
- Determination of Regulatory Review Period for Purposes of Patent Extension; ANKTIVA
- Determination of Regulatory Review Period for Purposes of Patent Extension; ANZUPGO
- Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers To Advance Pregnancy Safety Data Collection and Improve Health Communications
- Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEMBRY
- Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products
- Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-2027 Southern Hemisphere Influenza Virus Vaccines
- Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry; Availability
- Advancing Development of Botanical Drug Products; Request for Information
- Determination That PHENAPHEN WITH CODEINE NO. 3 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 30 Milligrams, and PHENAPHEN WITH CODEINE NO. 4 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- 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); 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: Genotoxicity Testing (Revision 2); Guidance for Industry; Availability
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product; GENGLYCOS (parisglasgene brecaparvovec-opnr)
- Dental Composite Resin Devices and Dental Curing Lights-Premarket Notification (510(k)) Submissions Guidances; Guidances for Industry and Food and Drug Administration Staff; Availability
- Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage; Draft Guidance for Industry; Availability
- Determination That CARAFATE (Sucralfate) Oral Suspension, 1 Gram/10 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Determination That NAMENDA (Memantine Hydrochloride) Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
August 2026
- Rahim Shafa; Denial of Hearing; Final Debarment Order
- Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Removals and Corrections
- Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated Fees
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Potential Tobacco Product Violations Reporting Form
- Authorization of Emergency Use for Three Animal Drugs for the Prevention and Treatment of New World Screwworm; Availability
- Compounding Animal Drugs From Bulk Drug Substances: Compounding Under CGMP in Federally-Registered Facilities; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
- Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups and Interviews as Used by the Food and Drug Administration
- Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Associated With Animal Drug and Animal Generic Drug User Fees
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Importation of Prescription Drugs
- Agency Information Collection Activities; Proposed Collection; Comment Request; Qualitative Feedback on Agency Service Delivery
- Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Second Extension of Effective Date of Final Resolution of Drug Efficacy Study Implementation 7661
- Agency Information Collection Activities; Proposed Collection; Comment Request; Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health
- International Drug Scheduling; Single Convention on Narcotic Drugs; Convention on Psychotropic Substances; Clobromazolam (Phenazolam); Cychlorphine (N-Propionitrile Chlorphine); Desalkylgidazepam (Bromonordiazepam); Ethylbromazolam; Etomethazene (5-Methyl Etodesnitazene); Spirochlorphine (R6980); Etomidate; Medetomidine; Request for Comments
- Determination That CABAZITAXEL (Cabazitaxel) Solution (Injection), 60 Milligrams/6 Milliliters (10 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Evaluation of Therapeutic Equivalence; Guidance for Industry; Availability
- Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
- Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 066
- Advisory Committee; Oncologic Drugs Advisory Committee; Renewal
- Frequently Asked Questions-Developing Potential Cellular and Gene Therapy Products; Final Guidance for Industry; Availability
- Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry; Availability
- Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee; Renewal
- Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee; Renewal
- GNT USA, LLC.; Filing of Color Additive Petition
- Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate
- International Association of Color Manufacturers; Filing of Color Additive Petition
- Gardenia Blue Interest Group; Filing of Color Additive Petition
- Testosterone Use in Menopausal Women; Public Workshop; Request for Comments
- Determining Whether To Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; Availability
- Type VII Veterinary Master File for Research and Development and Risk Reviews; Guidance for Industry; Availability
- Agency Information Collection Activities; Proposed Collection; Comment Request; Imports and Electronic Import Entries
- Determination of Regulatory Review Period for Purposes of Patent Extension; BIZENGRI
- Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food
- Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
- Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product
- Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer
- Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments
- Container Closure Systems for Human Drugs and Biological Products; Draft Guidance for Industry; Availability
- Determination That LASIX (Furosemide) Tablets, 20 Milligrams, 40 Milligrams, and 80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments
- Determination That ANSAID (Flurbiprofen) Tablets, 50 Milligrams and 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Guidance for Industry; Availability
- Kremers Urban Pharmaceuticals, Inc.; Grant of Hearing Request Regarding a Proposal To Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets
- Guide To Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce; Guidance for Industry; Availability
- Substances Generally Recognized as Safe
- Reauthorization of the Generic Drug User Fee Amendments; Public Meeting; Request for Comments
- Radiology Devices; Reclassification of Digital Breast Tomosynthesis System
- Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-GRAIL, Inc. Galleri
- Determination of Regulatory Review Period for Purposes of Patent Extension; DAYVIGO
- Determination of Regulatory Review Period for Purposes of Patent Extension; BRINSUPRI
- Determination That OZOBAX (Baclofen) Oral Solution, 5 Milligrams/5 Milliliters Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to their Microbiological Effects on Bacteria of Human Health Concern; Guidance for Industry; Availability
- Medical Devices; Radiology Devices; Classification of the Fludeoxyglucose F18-Guided Radiation Therapy System
- Authorization of Emergency Use of an In Vitro Diagnostic Device in Response to an Outbreak of Mpox; Availability
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Advisory Committees
- Establishment of a Quantitative Medicine Innovation Network: Scope, Feasibility, and Opportunities; Request for Information
- Micro-Tracers, Inc.; Response to Objections and Requests for a Public Hearing
- Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Revised Draft Guidance for Industry; Availability
- Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs; Guidance for Industry; Availability
- Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Draft Guidance for Industry; Availability
- Angela Anatilde Baquero: Final Debarment Order
- Ricardo Andres Acuna: Final Debarment Order
- Modification of Certain Terminology in Title 21; Reopening of the Comment Period
July 2026
- Prescription Drug User Fee Rates for Fiscal Year 2027
- Medical Device User Fee Rates for Fiscal Year 2027
- Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2027
- Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2027
- Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2027
- Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2027
- Outsourcing Facility Fee Rates for Fiscal Year 2027
- Generic Drug User Fee Rates for Fiscal Year 2027
- Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027
- Food Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2027
- Biosimilar User Fee Rates for Fiscal Year 2027
- Butylated Hydroxytoluene (BHT); Request for Information; Reopening of Comment Period
- Product-Specific Guidances; Revised Draft Guidances for Industry; Availability
- Statement of Organization, Functions, and Delegations of Authority
- Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy
- Fee Rate for Using a Priority Review Voucher in Fiscal Year 2026; Correction
- Agency Information Collection Activities; Proposed Collection; Comment Request; Expanded Access to Investigational Drugs for Treatment Use
- Pediatric Advisory Committee (PAC); Notice of Meeting; Establishment of a Public Docket; Request for Comments
- Cancer Clinical Trial Eligibility Criteria: Performance Status; Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability
- Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability
- Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees
- Medical Devices; Gastroenterology-Urology Devices; Classification of the Non-Medicated Topical Formulation for Treatment of Erectile Dysfunction
- Medical Devices; General Hospital and Personal Use Devices; Classification of the Active Noise Attenuation System for Infant Incubators
- Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Chronic Kidney Disease Progression
- Medical Devices; Immunology and Microbiology Devices; Classification of the Over-the-Counter Test To Detect SARS-CoV-2 From Clinical Specimens
- Medical Devices; General Hospital and Personal Use Devices; Classification of the Diabetes Digital Behavioral Therapeutic Device
- Medical Devices; Orthopedic Devices; Classification of the Intraoperative Surgical Angle Measurement Tool
- Francis Esteban Matos: Final Debarment Order
- Cellular, Tissue, and Gene Therapies Advisory Committee; Amendment of Notice-Biologics License Application (BLA) 125842 From Capricor, Inc. for Deramiocel (Human Allogeneic Cardiosphere-Derived Cells)
- Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologics License Application (BLA) 125827, From Replimune, Inc. for Vusolimogene Oderparepvec
- Evonik Corporation, Filing of Food Additive Petition (Animal Use)
- Advisory Committee; Peripheral and Central Nervous System Drugs Advisory Committee; Termination and Reestablishment
- FDA's Strategy Document on Facilitating Chemistry, Manufacturing, and Controls Readiness for Products With Accelerated Clinical Development
- Proposal To Revoke the Color Additive Listing for Use of Citrus Red No. 2 on the Skins of Mature Oranges
- Revocation of the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausages
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notifications Submission
- Determination That RASUVO (Methotrexate) Solution, 27.5 Milligrams/0.55 Milliliter (27.5 Milligrams/0.55 Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Expedited Investigational New Drug Pilot Program; Request for Information; Extension of the Comment Period
- Food Standards of Identity Modernization; Pasteurized Orange Juice
- Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Cosmetic Products
- Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary National Retail Food Regulatory Program Standards
- Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Voluntary Improvement Program
- Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements
- Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Devices: (Medical Product Safety Network (MedSun))
- Agency Information Collection Activities; Proposed Collection; Comment Request; Accreditation Scheme for Conformity Assessment Program
- Process for FDA Data Requests To Inform Certain Over-the-Counter Monograph Drug Activities; Procedure
- Topical Dermatologic Corticosteroids: In Vivo Bioequivalence; Guidance for Industry; Availability
- Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs
- Considerations for Potential Future Therapeutic Use of Psychedelic Drugs; Public Hearing; Request for Comments
- Psychedelic Drugs: Considerations for Clinical Investigations; Guidance for Industry; Availability
- Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
- Determination That TOVALT ODT (Zolpidem Tartrate) Orally Disintegrating Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Medical Device User Fee Amendments; Public Meeting; Request for Comments
- Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologics License Application (BLA) 125827, From Replimune, Inc. for Vusolimogene Oderparepvec
- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor
- Determination That VASOPRESSIN IN SODIUM CHLORIDE (vasopressin) 0.9%, Injection, 50 units/50 milliliters (1 unit/milliliters) 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; Premarket Approval of Medical Devices
- Agency Information Collection Activities; Proposed Collection; Comment Request; Biologics License Applications, Procedures and Requirements
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Practices and Procedures; Formal Hearings
- Expedited Investigational New Drug Pilot Program; Request for Information; Correction
- Endo Operations Limited, et al.; Withdrawal of Approval of 34 New Drug Applications
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medication Guides for Prescription Drug Products
June 2026
- Medical Devices; General and Plastic Surgery Devices; Classification of the Skin Patch for Treatment of Hyperhidrosis
- Medical Devices; Anesthesiology Devices; Classification of the Monitor for Opioid Induced Impairment of Oxygenation
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Minor Use and Minor Species
- Determination of Regulatory Review Period for Purposes of Patent Extension; VYALEV
- Establishment Registration and Product Listing for Tobacco Products
- Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologics License Application (BLA) 125842 From Capricor, Inc. for Deramiocel (Human Allogeneic Cardiosphere-Derived Cells)
- Medical Devices; Orthopedic Devices; Classification of the Medial Knee Implanted Shock Absorber
- Agency Information Collection Activities; Proposed Collection; Comment Request; Time and Extent Applications for Nonprescription Drug Products
- Medical Devices; General Hospital and Personal Use Devices; Classification of the Foam or Gel Chemical Sterilant/High Level Disinfectant
- Medical Devices; Clinical Chemistry and Toxicology Devices; Classification of the Prognostic Test for Development or Progression of Preeclampsia
- Medical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for the Treatment of Fibromyalgia Symptoms
- Medical Devices; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test
- Medical Devices; General and Plastic Surgery Devices; Classification of the Breast Implant Suction Retrieval System
- Medical Devices; Neurological Devices; Classification of the External Lower Extremity Nerve Stimulator for Restless Legs Syndrome
- Medical Devices; General Hospital and Personal Use Devices; Classification of the Infant Supine Sleep System
- Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
- Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Extension of Effective Date of Final Resolution of Drug Efficacy Study Implementation 7661
- List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period
- Determination That RECTIV (Nitroglycerin) Ointment, 0.4%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Determination That Prednisolone Tablet, 5 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Sterigenics U.S., LLC; Filing of Food Additive Petition
- Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials; Draft Guidance for Industry; Availability
- Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Availability
- Expedited Investigational New Drug Pilot Program; Request for Information
- Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Revised Draft Guidance for Industry; Availability
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: General Recommendations; Guidance for Industry; Availability
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Bovines; Guidance for Industry; Availability
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Ovines; Guidance for Industry; Availability
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Caprines; Guidance for Industry; Availability
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Equines; Guidance for Industry; Availability
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Porcines; Guidance for Industry; Availability
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Canines; Guidance for Industry; Availability
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Felines; Guidance for Industry; Availability
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Chickens-Gallus Gallus; Guidance for Industry; Availability
- Agency Information Collection Activities; Proposed Collection; Comment Request; Potential Tobacco Product Violations Reporting Form
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification of Identity, Form FDA 3975
- Epizyme, Inc.; Withdrawal of Approval of New Drug Application for TAZVERIK (Tazemetostat) Tablet, 200 Milligrams
- Medical Devices; Immunology and Microbiology Devices; Classification of the Simple In Vitro Diagnostic Device for the Detection of Secreted Proteins From Bacillus Species (spp.) in Human Clinical Samples
- Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Light-Projecting Measuring Device
- Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Traction Device
- Advisory Committee; Science Board to the Food and Drug Administration; Renewal
- SpecGx LLC; Withdrawal of Approval of Abbreviated New Drug Application for Methylphenidate Hydrochloride Extended-Release Tablets, 27 Milligrams, 36 Milligrams, and 54 Milligrams
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles and Medicated Feeds
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
- Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals
- Authorization of Emergency Use for Two Animal Drugs for the Prevention and Treatment of New World Screwworm; Availability
- Medical Devices; Gastroenterology-Urology Devices; Classification of the Ingestible Gastrointestinal Blood Detection Capsule
- Medical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan
- Andrew Jonathan Morgan: Final Debarment Order
- Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, et al.; Withdrawal of Approval of 11 Abbreviated New Drug Applications; Correction
- Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability
- Amendment and Revocation of Organizational Information Regulations
- Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments; Reopening of the Comment Period
- Drug Repurposing for Unmet Medical Needs; Request for Information; Extension of Comment Period
- Medical Devices; Immunology and Microbiology Devices; Classification of the Simple Point-of-Care Device to Directly Detect SARS-CoV-2 Viral Targets From Clinical Specimens in Near-Patient Settings
- Medical Devices; Immunology and Microbiology Devices; Classification of the Spinal Muscular Atrophy Newborn Screening Test System
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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; Procedures for the Safe Processing and Importing of Fish and Fishery Products
- Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information
- Medical Devices; Ear, Nose, and Throat Devices; Classification of the Combined Acoustic and Electrical External Stimulation Device for the Relief of Tinnitus
- Determination That Protamine Sulfate (Protamine Sulfate) Intravenous; Solution, 50 Milligrams/5 Milliliters, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Medical Devices; Orthopedic Devices; Classification of the Absorbable Metallic Bone Fixation Fastener
- Intent To Exempt Certain Unclassified Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability
- Medical Devices; Orthopedic Devices; Classification of the Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented or Uncemented Prosthesis
- Medical Devices; Orthopedic Devices; Classification of the Resorbable Calcium Salt Bone Void Filler Containing a Single Approved Aminoglycoside Antibacterial
- Vanda Pharmaceuticals, Inc.; Grant of Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon)
- Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry; Availability
- Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability
- Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications
- Third Annual Animal Drug User Fee Educational Conference; Public Meeting
- 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
- M15 General Principles for Model-Informed Drug Development; International Council for Harmonisation; Guidance for Industry; Availability
- Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability
- Medical Devices; Ear, Nose, and Throat Devices; Classification of the Oropharyngeal Electrical Stimulator
- Medical Devices; Hematology and Pathology Devices; Classification of the Von Willebrand Factor Assay
- Medical Devices; Dental Devices; Classification of the Intraoral Cooling Device
- Medical Devices; Gastroenterology-Urology Devices; Classification of the Orally Ingested Transient Device for Constipation
- Medical Devices; Anesthesiology Devices; Classification of the Adjunctive Pain Measurement Device for Anesthesiology
- Medical Devices; Anesthesiology Devices; Classification of the Real-Time Ultrasound Anatomy Visualization and Labeling Device for Ultrasound Guided Regional Anesthesia
- Medical Devices; General Hospital and Personal Use Devices; Classification of the Rigid Sterilization Container With Electronic Monitoring
May 2026
- Advisory Committee; Psychopharmacologic Drugs Advisory Committee; Renewal
- Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms
- Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Guidance for Industry; Availability
- Statistical Approaches To Establishing Bioequivalence; Guidance for Industry; Availability
- Content of Human Factors Information in Medical Device Marketing Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
- Patient-Focused Drug Development for Nonhealing Chronic Wounds; Public Meeting; Request for Comments
- AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information; Extension of Comment Period
- Challenges and Solutions in Lot-Level Food Traceability; Public Meeting and Request for Comments
- 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; Reopening of the Comment Period
- 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; Reopening of the Comment Period
- Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Suturing Device for Altering Gastric Anatomy for Weight Loss
- Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Syntest D.S. and Syntest H.S. Tablets; Withdrawal of Hearing Requests; Final Resolution of Drug Efficacy Study Implementation 7661
- Advisory Committee; Drug Safety and Risk Management Advisory Committee; Renewal
- Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
- Advisory Committee; Pulmonary-Allergy Drugs Advisory Committee; Renewal
- Notice of Decision Not To Designate Hepatitis Delta Virus Diseases as an Addition to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act
- Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
- Protein Efficiency Ratio Rat Bioassay Studies To Demonstrate That a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein; Guidance for Industry; Availability
- M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP); International Council for Harmonisation; Guidance for Industry; Availability
- Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Safety and Effectiveness of MFLUSIVA (Influenza Vaccine, mRNA) Manufactured by Moderna TX Inc.
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Required Warnings for Cigarette Packages and Advertisements
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Active Pharmaceutical Ingredients) and the Advanced Manufacturing Technologies Designation Program
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience/Events With Approved New Animal Drugs
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Patent Term Restoration; Due Diligence Petitions; Filing, Format, and Content of Petitions
- Oscar Bobo: Final Debarment Order
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; The Real Cost Campaign Outcomes Evaluation Study: Cohort 3
- Butylated Hydroxytoluene (BHT); Request for Information
- Azodicarbonamide (ADA); Request for Information
- Biomarker Incubator: Urinary Kidney Safety Biomarkers; Request for Information
- Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting
- Modified Risk Tobacco Product Application: Renewal Applications for VLN® King and VLN® Menthol King, Cigarette Products Submitted by 22nd Century Group Inc.
- Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microorganism Nucleic Acids and Resistance Markers From Patients With Suspected Orthopedic Infection
- Drug Repurposing for Unmet Medical Needs; Request for Information
- Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization; Guidance for Industry; Availability
- 21st Century Cures Act: Annual Compilation of Notices of Updates From the Susceptibility Test Interpretive Criteria web page
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product; AVLAYAH (tividenofusp alfa-eknm)
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications On Medical Devices and Radiation-Emitting Products
- Clostridioides Difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, or Prevention; Guidance for Industry; Availability
- Postapproval Pregnancy Safety Studies; Guidance for Industry; Availability
- Pulmonary Tuberculosis: Developing Drugs for Treatment; Guidance for Industry; Availability
- Animal Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intent To Participate
- Animal Generic Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Generic Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intent To Participate
- Medical Devices; Obstetrical and Gynecological Devices; Classification of the External Condom for Anal Intercourse or Vaginal Intercourse
- Determination That Leucovorin Calcium, Oral Solution, Equivalent to 60 Milligrams Base/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Determination That MICARDIS (Telmisartan), Tablets, 20 Milligrams and 80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications
- Patient-Matched Guides for Orthopedic Implants; Guidance for Industry and Food and Drug Administration Staff; Availability
- Advisory Committee; Blood Products Advisory Committee; Renewal
- Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Preserve and Stabilize Relative Abundances of Microbial Nucleic Acids in Clinical Samples
- Medical Devices; Immunology and Microbiology Devices; Classification of the Circulating Tumor Cell Enrichment Device
- Medical Devices; Ophthalmic Devices; Classification of the Corneal Storage Medium With Preservatives Including Antifungals
- Modification of Certain Terminology in Title 21
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product; OTARMENI (lunsotogene parvec-cwha)
- Determination That DEXAMETHASONE (Dexamethasone) Elixir, 0.5 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Agency Information Collection Activities; Proposed Collection; Comment Request; National Youth Tobacco Survey
- Medical Devices; General and Plastic Surgery Devices; Classification of the Phototherapy Device for Reducing the Appearance of Acute Post-Surgical Incisions
- Medical Devices; Exemptions From Premarket Notification: Certain Class II Devices; Request for Comments
- Obesity and Drug Dosing: Clinical Pharmacology Considerations; Request for Comments
- Impacts of Patient-Focused Drug Development Meetings; Establishment of a Public Docket; Request for Information and Comments
- List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act
April 2026
- Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Requirements for Nonclinical Laboratory Studies
- Advisory Committee; Pharmacy Compounding Advisory Committee; Renewal
- Determination FENOGLIDE (Fenofibrate) Tablets, 40 Milligrams and 120 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; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice
- Medical Devices; Radiology Devices; Classification of the Radiation Therapy Marking Device
- Medical Devices; Neurological Devices; Classification of the Brain Temperature Measurement System
- Medical Devices; Cardiovascular Devices; Classification of the Laser-Powered Inferior Vena Cava Filter Retrieval Catheter
- Determination That OZEMPIC (Semaglutide) Solution, 2 Milligrams Per 1.5 Milliliters Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- ChemoCentryx, Inc.; Proposal To Withdraw Approval of New Drug Application for TAVNEOS (Avacopan) Capsule, 10 Milligrams; Opportunity for a Hearing
- AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information
- Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-United States (U.S.) 2026-2027 Formula for COVID-19 Vaccine Composition
- Advisory Committee; Anesthetic and Analgesic Drug Products Advisory Committee; Renewal
- Egis Pharmaceuticals Limited, et al.; Withdrawal of Approval of Three Abbreviated New Drug Applications
- Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability
- Kimberly Schaff Kiehl: Final Debarment Order
- Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke; Established List Additions and Request for Comments
- Commissioner's National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for Comments; Amendment
- Medical Devices; Immunology and Microbiology Devices; Classification of the Alzheimer's Disease Pathology Assessment Test
- Medical Devices; Ophthalmic Devices; Classification of the Digital Therapy Device for Amblyopia
- Medical Devices; Anesthesiology Devices; Classification of the Device for Sleep Apnea Testing Based on Mandibular Movement
- Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Setmelanotide Eligibility Gene Variant Detection System
- Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Potential New Indication for Testosterone Replacement Therapy
- Establishing Impurity Specifications for Antibiotics; Draft Guidance for Industry; Availability
- Animal Generic Drug User Fee Act; Public Meeting; Request for Comments
- Animal Drug User Fee Act; Public Meeting; Request for Comments
- Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed
- Agency Information Collection Activities; Proposed Collection; Comment Request; Radioactive Drug Research Committees
- Authorization of Emergency Use for Four Animal Drugs for the Treatment of New World Screwworm; 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
- Medical Devices; Ear, Nose, and Throat Devices; Classification of the Transcutaneous Electrical Nerve Stimulator for the Relief of Congestion
- Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators
- Medical Devices; Orthopedic Devices; Classification of the Manual Surgical Instrument for Appropriate Patient Selection for Orthopedic Implant
- Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted)
- Notice of Approval of Product Under Priority Review Voucher; Material Threat Medical Countermeasure Priority Review Voucher; MRESVIA (Respiratory Syncytial Virus Vaccine)
- Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; MRESVIA (Respiratory Syncytial Virus Vaccine)
- Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; MNEXSPIKE (COVID-19 Vaccine, mRNA)
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Stability Testing for Medicated Premixes (Revision 1); Draft Guidance for Industry; Availability
- Agency Information Collection Activities; Proposed Collection; Comment Request; Importation of Prescription Drugs
- Determination of Regulatory Review Period for Purposes of Patent Extension; UNLOXCYT
- Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs
- Determination That CHEWTADZY (Tadalafil) Chewable Tablets, 5 Milligrams, 10 Milligrams, 20 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Determination That REVIA (Naltrexone Hydrochloride) Tablets, 50 Milligrams Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address
- 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
- Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability
- Increasing Access to Nonprescription Drugs; Public Meeting; Request for Comments
- Determination That BILTRICIDE (Praziquantel) Oral Tablet, 600 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices
- GlaxoSmithKline; Withdrawal of Approval of a New Drug Application for Wellcovorin (Leucovorin Calcium) Tablets, EQ 5 mg Base and EQ 25 mg Base
- Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503
- Agency Information Collection Activities; Proposed Collection; Comment Request; Color Additive Certification
- Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Practices and Procedures; Formal Hearings
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product; LOARGYS (pegzilarginase-nbln)
- Electronic Submission of Postmarketing Individual Case Safety Reports to the Food and Drug Administration Adverse Event Monitoring System Using International Council of Harmonisation E2B(R3) Data Standards; Regional Data Elements and Implementation Schedule
- Determination That STRATTERA (Atomoxetine Hydrochloride) Capsules 5 Milligrams, 10 Milligrams, 18 Milligrams, 25 Milligrams, 40 Milligrams, 60 Milligrams, 80 Milligrams, and 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Determination of Regulatory Review Period for Purposes of Patent Extension; ZIIHERA
- Determination of Regulatory Review Period for Purposes of Patent Extension; ENCELTO
- Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY
- Determination of Regulatory Review Period for Purposes of Patent Extension; ENFLONSIA
- Determination of Regulatory Review Period for Purposes of Patent Extension; EMRELIS
- Determination of Regulatory Review Period for Purposes of Patent Extension; HYMPAVZI
- Agency Information Collection Activities; Proposed Collection; Comment Request; Customer/Partner Customer Service Satisfaction Surveys
- Determination of Regulatory Review Period for Purposes of Patent Extension; INJECTAFER
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product; KRESLADI (marnetegragene autotemcel)
- Consideration of Acceptable Market Name Change for Certain Rockfish (Sebastes spp.); Request for Information
- Filing of Color Additive Petition From the International Association of Color Manufacturers; Request To Amend the Color Additive Regulations To Remove the Solvents Methylene Chloride, Trichloroethylene, and Ethylene Dichloride
- Determination That INAPSINE (Droperidol) Injection, 2.5 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product; YUVIWEL (navepegritide)
March 2026
- Advancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products; Request for Information and Comments
- Notice of Decision on a Hearing Request Regarding a Proposal To Refuse To Approve a New Drug Application for TRADIPITANT Capsules
- Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle; Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties; Availability
- Microbiology Devices; Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests
- Elite Laboratories, Inc., et al.; Withdrawal of Approval of 72 Abbreviated New Drug Applications; Correction
- General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Software-Aided Adjunctive Diagnostic Devices for Use on Skin Lesions by Physicians Trained in the Diagnosis and Management of Skin Cancer
- Listing of Color Additive Exempt From Certification; Beetroot Red; Delay of Effective Date
- Listing of Color Additive Exempt From Certification; Spirulina Extract; Delay of Effective Date
- Commissioner's National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for Comments
- Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Associated With Animal Drug and Animal Generic Drug User Fees
- Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Advisory Committees
- Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notifications Submission
- General Considerations for the Use of New Approach Methodologies in Drug Development; Draft Guidance for Industry; Availability
- Labeling and Preventing Cross-Contact of Gluten for Packaged Foods; Request for Information; Extension of Comment Period
- Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in Abbreviated New Drug Applications; Guidance for Industry, Availability
- Over-the-Counter Monograph Drug Facility Fee Rates for Fiscal Year 2026
- Preparation for International Cooperation on Cosmetics Regulation Twentieth Annual Meeting (ICCR-20); Request for Comments
- Determination That METHERGINE (Methylergonovine Maleate) Injection, 0.2 Milligram/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Advisory Committee; Obstetrics, Reproductive and Urologic Drugs Advisory Committee; Renewal
- Medical Devices; Radiology Devices; Classification of Blood Irradiators
- Effective Date of Requirement for Premarket Approval Applications for Blood Irradiators Intended To Prevent Metastasis
- General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products; Withdrawal of Proposed Rule
- Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; EYLEA HD (aflibercept)
- Medical Devices With Indications Associated With Weight Loss-Premarket Considerations; Guidance for Industry and Food and Drug Administration Staff; Availability
- Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mammography Standards Quality Act Requirements
- Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Food and Egg Regulatory Program Standards
- Watson Laboratories, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications
- Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications-Considerations Related to Youth Risk; Draft Guidance for Industry; Availability
- New and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act; Draft Guidance for Industry; Availability
- Determination of Regulatory Review Period for Purposes of Patent Extension; AURORA EV-ICD
- Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-New Drug Application 220359, for Camizestrant Tablets; Supplemental New Drug Application (sNDA) 218197/S-004, for Truqap (Capivasertib) Tablets
- Aspen Global Inc. c/o Lachman Consultant Services, Inc., et al.; Withdrawal of Approval of 46 New Drug Applications
- Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry; Availability
- Developing Specifications for In-Home Disposal Systems for Opioid Analgesics Dispensed in an Outpatient Setting; Establishment of a Public Docket; Request for Comments
- Determination of Regulatory Review Period for Purposes of Patent Extension; ENSACOVE
- Revising the National Drug Code Format and Drug Label Barcode Requirements
- E2D(R1) Postapproval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports; International Council for Harmonisation; Guidance for Industry; Availability
- M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-Interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines; International Council for Harmonisation; Guidance for Industry; Availability
- Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use)
- Ecoflora Cares; Filing of Color Additive Petition
- New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
- Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments
February 2026
- International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Scheduling Recommendations; N-Pyrrolidino Isotonitazene; N-Desethyl Etonitazene; Coca Leaf; MDMB-FUBINACA; Request for Comments
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ZYCUBO (Copper Histidinate)
- Fiscal Year 2026 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments
- Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
- Determination of Regulatory Review Period for Purposes of Patent Extension; REVUFORJ
- Determination of Regulatory Review Period for Purposes of Patent Extension; ORLYNVAH
- Determination of Regulatory Review Period for Purposes of Patent Extension; AEROPACE
- Determination of Regulatory Review Period for Purposes of Patent Extension; TRYNGOLZA
- Determination of Regulatory Review Period for Purposes of Patent Extension; TEVIMBRA
- Determination of Regulatory Review Period for Purposes of Patent Extension; MERIT MEDICAL WRAPSODY
- Determination of Regulatory Review Period for Purposes of Patent Extension; LIMFLOW SYSTEM
- Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records
- Considerations for the Use of the Plausible Mechanism Framework To Develop Individualized Therapies That Target Specific Genetic Conditions With Known Biological Cause; Draft Guidance for Industry; Availability
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Retailer Training Programs
- Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds
- Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing.
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
- Advisory Committee; Gastrointestinal Drugs Advisory Committee; Renewal
- Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product; WASKYRA (etuvetidigene autotemcel)
- Determination That Klonopin (Clonazepam) Tablets, 0.125 Milligrams and 0.25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Active Pharmaceutical Ingredients) and the Advanced Manufacturing Technologies Designation Program
- Agency Information Collection Activities; Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice
- Agency Information Collection Activities; Proposed Collection; Comment Request; Approved Organizations for Wholesale Drug Distributors and Third-Party Logistics Providers
- Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Events Associated With New Animal Drugs
- Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Minor Use and Minor Species
- Requirements for Additional Traceability Records for Certain Foods; Exemption for Cottage Cheese Regulated by the National Conference on Interstate Milk Shipments Grade “A” Pasteurized Milk Ordinance
- Questions and Answers About Requirements for Additional Traceability Records for Certain Foods; Draft Guidance for Industry; Availability
- Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, et al.; Withdrawal of Approval of 11 Abbreviated New Drug Applications
- Revocation of Authorization of Emergency Use of ExThera Medical Corporation Seraph 100 Microbind Affinity Blood Filter (Seraph 100); Availability
- Sherrie R. McCain: Final Debarment Order
- Justin Insprucker: Final Debarment Order
- Sherri Insprucker: Final Debarment Order
- Revocation of Methods of Analysis Regulation
- 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
- Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 065
- Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe Processing and Importing of Fish and Fishery Products
- Determination of Regulatory Review Period for Purposes of Patent Extension; SYMVESS
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emerging Drug Safety Technology Program
- Agency Information Collection Activities; Proposed Collection; Comment Request; Patent Term Restoration; Due Diligence Petitions; Filing, Format, and Content of Petitions
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Quick Turnaround Testing of Communication Effectiveness
- 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; Submission for Office of Management and Budget Review; Comment Request; Electronic Products Requirements
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents
- 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
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ZEVASKYN (Prademagene Zamikeracel)
- Determination That TOLECTIN DS (Tolmetin Sodium) Capsule, Equivalent to 400 Milligrams Base, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Determination of Regulatory Review Period for Purposes of Patent Extension; BLUJEPA
- Determination of Regulatory Review Period for Purposes of Patent Extension; RYTELO
- Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals; Guidance for Industry; Availability
- Determination of Regulatory Review Period for Purposes of Patent Extension; ALYFTREK
- Determination of Regulatory Review Period for Purposes of Patent Extension; ATTRUBY
- Determination of Regulatory Review Period for Purposes of Patent Extension; AUCATZYL
- Determination of Regulatory Review Period for Purposes of Patent Extension; CRENESSITY
- Determination of Regulatory Review Period for Purposes of Patent Extension; AMTAGVI
- Determination of Regulatory Review Period for Purposes of Patent Extension; KEBILIDI
- Jeremy Spencer Brown: Final Debarment Order
- Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-United States (U.S.) 2026-2027 Influenza Vaccine Strain Composition
- Certification Process for Designated Medical Gases; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
- Butylated Hydroxyanisole (BHA); Request for Information
- Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program
- Listing of Color Additives Exempt From Certification; Beetroot Red
- Listing of Color Additives Exempt From Certification; Spirulina Extract
- E22 General Considerations for Patient Preference Studies; International Council for Harmonisation; Draft Guidance for Industry; Availability
- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address
- Paul Zachary Lamberty: Final Debarment Order
- Matthew Teltser: Final Debarment Order
- Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments
- Determination of Regulatory Review Period for Purposes of Patent Extension; AURORA EV-ICD
- Determination of Regulatory Review Period for Purposes of Patent Extension; ALFAPUMP
- Agency Information Collection Activities; Proposed Collection; Comment Request; Expedited Programs for Serious Conditions-Accelerated Approval of Drugs and Biologics
- Determination of Regulatory Review Period for Purposes of Patent Extension; BEQVEZ
- Determination of Regulatory Review Period for Purposes of Patent Extension; COBENFY
January 2026
- FDA Rare Disease Innovation Hub Future Programming; Request for Comments
- Determination of Regulatory Review Period for Purposes of Patent Extension; TRYVIO
- Determination of Regulatory Review Period for Purposes of Patent Extension; Symplicity Spyral Renal Denervation System
- Determination of Regulatory Review Period for Purposes of Patent Extension; IMAAVY
- Agency Information Collection Activities; Proposed Collection; Comment Request; Medication Guides for Prescription Drug Products
- Determination of Regulatory Review Period for Purposes of Patent Extension; BIMZELX
- Determination of Regulatory Review Period for Purposes of Patent Extension; REZDIFFRA
- Determination of Regulatory Review Period for Purposes of Patent Extension; EXBLIFEP
- Determination of Regulatory Review Period for Purposes of Patent Extension; RYZNEUTA
- Cuffless Non-Invasive Blood Pressure Measuring Devices-Clinical Performance Testing and Evaluation; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Tyler Jordan Hall: Final Debarment Order
- Labeling and Preventing Cross-Contact of Gluten for Packaged Foods; Request for Information
- FDA Records Access Authority for Cosmetics; Draft Guidance for Industry; Availability
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product; KYGEVVI (Doxecitine and Doxribtimine)
- Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints To Support Accelerated Approval; Draft Guidance for Industry; Availability
- Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability
- M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality; International Council for Harmonisation; Draft Guidance for Industry; Availability
- Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; RHAPSIDO (Remibrutinib)
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Warning Plans for Certain Tobacco Products
- Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products; Draft Guidance for Industry; Availability
- Determination of Regulatory Review Period for Purposes of Patent Extension; ZURZUVAE
- Determination of Regulatory Review Period for Purposes of Patent Extension; IZERVAY
- Determination of Regulatory Review Period for Purposes of Patent Extension; MEDIBEACON
- Determination of Regulatory Review Period for Purposes of Patent Extension; BRENZAVVY
- Determination of Regulatory Review Period for Purposes of Patent Extension; AUGTYRO
- Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
- Determination That MYSOLINE (Primidone) Suspension, 250 Milligrams/5 Milliliters, Was Withdrawn From Sale for Reasons of Safety or Effectiveness
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.