Agency Archive
Food and Drug Administration
Recent Federal Register documents and issues associated with this agency.
Recent Documents
- Butylated Hydroxytoluene (BHT); Request for Information; Reopening of Comment Period Thursday, July 30, 2026 91 FR 48127
- Biosimilar User Fee Rates for Fiscal Year 2027 Thursday, July 30, 2026 91 FR 48166
- Food Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2027 Thursday, July 30, 2026 91 FR 48125
- Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027 Thursday, July 30, 2026 91 FR 48121
- Generic Drug User Fee Rates for Fiscal Year 2027 Thursday, July 30, 2026 91 FR 48154
- Outsourcing Facility Fee Rates for Fiscal Year 2027 Thursday, July 30, 2026 91 FR 48142
- Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2027 Thursday, July 30, 2026 91 FR 48149
- Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2027 Thursday, July 30, 2026 91 FR 48128
- Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2027 Thursday, July 30, 2026 91 FR 48145
- Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2027 Thursday, July 30, 2026 91 FR 48118
- Medical Device User Fee Rates for Fiscal Year 2027 Thursday, July 30, 2026 91 FR 48134
- Prescription Drug User Fee Rates for Fiscal Year 2027 Thursday, July 30, 2026 91 FR 48160
- Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy Wednesday, July 29, 2026 91 FR 47788
- Statement of Organization, Functions, and Delegations of Authority Wednesday, July 29, 2026 91 FR 47835
- Product-Specific Guidances; Revised Draft Guidances for Industry; Availability Wednesday, July 29, 2026 91 FR 47834
- Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability Tuesday, July 28, 2026 91 FR 47245
- Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability Tuesday, July 28, 2026 91 FR 47247
- Cancer Clinical Trial Eligibility Criteria: Performance Status; Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability Tuesday, July 28, 2026 91 FR 47251
- Pediatric Advisory Committee (PAC); Notice of Meeting; Establishment of a Public Docket; Request for Comments Tuesday, July 28, 2026 91 FR 47243
- Agency Information Collection Activities; Proposed Collection; Comment Request; Expanded Access to Investigational Drugs for Treatment Use Tuesday, July 28, 2026 91 FR 47248
- Fee Rate for Using a Priority Review Voucher in Fiscal Year 2026; Correction Tuesday, July 28, 2026 91 FR 47252
- Medical Devices; General Hospital and Personal Use Devices; Classification of the Active Noise Attenuation System for Infant Incubators Monday, July 27, 2026 91 FR 46835
- Medical Devices; Gastroenterology-Urology Devices; Classification of the Non-Medicated Topical Formulation for Treatment of Erectile Dysfunction Monday, July 27, 2026 91 FR 46833
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees Monday, July 27, 2026 91 FR 46938
- Evonik Corporation, Filing of Food Additive Petition (Animal Use) Friday, July 24, 2026 91 FR 46761
- 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 Friday, July 24, 2026 91 FR 46788
- 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) Friday, July 24, 2026 91 FR 46789
- Francis Esteban Matos: Final Debarment Order Friday, July 24, 2026 91 FR 46789
- Medical Devices; Orthopedic Devices; Classification of the Intraoperative Surgical Angle Measurement Tool Friday, July 24, 2026 91 FR 46722
- Medical Devices; General Hospital and Personal Use Devices; Classification of the Diabetes Digital Behavioral Therapeutic Device Friday, July 24, 2026 91 FR 46719
- Medical Devices; Immunology and Microbiology Devices; Classification of the Over-the-Counter Test To Detect SARS-CoV-2 From Clinical Specimens Friday, July 24, 2026 91 FR 46716
- Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Chronic Kidney Disease Progression Friday, July 24, 2026 91 FR 46713
- Revocation of the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausages Thursday, July 23, 2026 91 FR 46276
- Proposal To Revoke the Color Additive Listing for Use of Citrus Red No. 2 on the Skins of Mature Oranges Thursday, July 23, 2026 91 FR 46330
- FDA's Strategy Document on Facilitating Chemistry, Manufacturing, and Controls Readiness for Products With Accelerated Clinical Development Thursday, July 23, 2026 91 FR 46443
- Advisory Committee; Peripheral and Central Nervous System Drugs Advisory Committee; Termination and Reestablishment Thursday, July 23, 2026 91 FR 46444
- 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 Wednesday, July 22, 2026 91 FR 46125
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notifications Submission Wednesday, July 22, 2026 91 FR 46123
- Expedited Investigational New Drug Pilot Program; Request for Information; Extension of the Comment Period Tuesday, July 21, 2026 91 FR 45820
- Food Standards of Identity Modernization; Pasteurized Orange Juice Monday, July 20, 2026 91 FR 45190
- Agency Information Collection Activities; Proposed Collection; Comment Request; Accreditation Scheme for Conformity Assessment Program Friday, July 17, 2026 91 FR 44854
- Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Devices: (Medical Product Safety Network (MedSun)) Friday, July 17, 2026 91 FR 44863
- Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements Friday, July 17, 2026 91 FR 44859
- Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Voluntary Improvement Program Friday, July 17, 2026 91 FR 44852
- Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary National Retail Food Regulatory Program Standards Friday, July 17, 2026 91 FR 44857
- Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Cosmetic Products Friday, July 17, 2026 91 FR 44850
- 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 Wednesday, June 24, 2026 91 FR 37988
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Felines; Guidance for Industry; Availability Wednesday, June 24, 2026 91 FR 38003
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Canines; Guidance for Industry; Availability Wednesday, June 24, 2026 91 FR 37986
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Porcines; Guidance for Industry; Availability Wednesday, June 24, 2026 91 FR 38001
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Equines; Guidance for Industry; Availability Wednesday, June 24, 2026 91 FR 37985
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Caprines; Guidance for Industry; Availability Wednesday, June 24, 2026 91 FR 37993
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Ovines; Guidance for Industry; Availability Wednesday, June 24, 2026 91 FR 38000
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Bovines; Guidance for Industry; Availability Wednesday, June 24, 2026 91 FR 37989
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: General Recommendations; Guidance for Industry; Availability Wednesday, June 24, 2026 91 FR 37983
- Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Revised Draft Guidance for Industry; Availability Wednesday, June 24, 2026 91 FR 37994
- Expedited Investigational New Drug Pilot Program; Request for Information Wednesday, June 24, 2026 91 FR 37996
- Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Availability Wednesday, June 24, 2026 91 FR 37991
- 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 Wednesday, June 24, 2026 91 FR 38004
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification of Identity, Form FDA 3975 Tuesday, June 23, 2026 91 FR 37410
- Agency Information Collection Activities; Proposed Collection; Comment Request; Potential Tobacco Product Violations Reporting Form Tuesday, June 23, 2026 91 FR 37410
- Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Traction Device Monday, June 22, 2026 91 FR 36982
- Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Light-Projecting Measuring Device Monday, June 22, 2026 91 FR 36980
- 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 Monday, June 22, 2026 91 FR 36976
- Epizyme, Inc.; Withdrawal of Approval of New Drug Application for TAZVERIK (Tazemetostat) Tablet, 200 Milligrams Monday, June 22, 2026 91 FR 37120
- Authorization of Emergency Use for Two Animal Drugs for the Prevention and Treatment of New World Screwworm; Availability Thursday, June 18, 2026 91 FR 36843
- Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals Thursday, June 18, 2026 91 FR 36868
- 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 Thursday, June 18, 2026 91 FR 36861
- 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 Thursday, June 18, 2026 91 FR 36863
- SpecGx LLC; Withdrawal of Approval of Abbreviated New Drug Application for Methylphenidate Hydrochloride Extended-Release Tablets, 27 Milligrams, 36 Milligrams, and 54 Milligrams Thursday, June 18, 2026 91 FR 36865
- Advisory Committee; Science Board to the Food and Drug Administration; Renewal Thursday, June 18, 2026 91 FR 36865
- Andrew Jonathan Morgan: Final Debarment Order Wednesday, June 17, 2026 91 FR 36603
- Medical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan Wednesday, June 17, 2026 91 FR 36522
- Medical Devices; Gastroenterology-Urology Devices; Classification of the Ingestible Gastrointestinal Blood Detection Capsule Wednesday, June 17, 2026 91 FR 36520
- Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, et al.; Withdrawal of Approval of 11 Abbreviated New Drug Applications; Correction Tuesday, June 16, 2026 91 FR 36145
- Amendment and Revocation of Organizational Information Regulations Monday, June 15, 2026 91 FR 35884
- Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability Monday, June 15, 2026 91 FR 35985
- 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 Thursday, June 11, 2026 91 FR 35484
- 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 Thursday, June 11, 2026 91 FR 35486
- Medical Devices; Immunology and Microbiology Devices; Classification of the Spinal Muscular Atrophy Newborn Screening Test System Thursday, June 11, 2026 91 FR 35384
- 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 Thursday, June 11, 2026 91 FR 35387
- Drug Repurposing for Unmet Medical Needs; Request for Information; Extension of Comment Period Thursday, June 11, 2026 91 FR 35488
- Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments; Reopening of the Comment Period Thursday, June 11, 2026 91 FR 35483
- Medical Devices; Ear, Nose, and Throat Devices; Classification of the Combined Acoustic and Electrical External Stimulation Device for the Relief of Tinnitus Wednesday, June 10, 2026 91 FR 35138
- Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information Wednesday, June 10, 2026 91 FR 35220
- 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 Monday, June 8, 2026 91 FR 34634
- Medical Devices; Orthopedic Devices; Classification of the Resorbable Calcium Salt Bone Void Filler Containing a Single Approved Aminoglycoside Antibacterial Friday, June 5, 2026 91 FR 34148
- Medical Devices; Orthopedic Devices; Classification of the Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented or Uncemented Prosthesis Friday, June 5, 2026 91 FR 34152
- Intent To Exempt Certain Unclassified Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability Friday, June 5, 2026 91 FR 34240
- Medical Devices; Orthopedic Devices; Classification of the Absorbable Metallic Bone Fixation Fastener Friday, June 5, 2026 91 FR 34146
- M15 General Principles for Model-Informed Drug Development; International Council for Harmonisation; Guidance for Industry; Availability Wednesday, June 3, 2026 91 FR 33179
- 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 Wednesday, June 3, 2026 91 FR 33071
- Third Annual Animal Drug User Fee Educational Conference; Public Meeting Wednesday, June 3, 2026 91 FR 33176
- Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications Wednesday, June 3, 2026 91 FR 33185
- Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability Wednesday, June 3, 2026 91 FR 33181
- Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry; Availability Wednesday, June 3, 2026 91 FR 33178
- Vanda Pharmaceuticals, Inc.; Grant of Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon) Wednesday, June 3, 2026 91 FR 33174
- Patient-Focused Drug Development for Nonhealing Chronic Wounds; Public Meeting; Request for Comments Friday, May 29, 2026 91 FR 32059
- Content of Human Factors Information in Medical Device Marketing Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability Friday, May 29, 2026 91 FR 32061
- Statistical Approaches To Establishing Bioequivalence; Guidance for Industry; Availability Friday, May 29, 2026 91 FR 32056
- Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Guidance for Industry; Availability Friday, May 29, 2026 91 FR 32057
- Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms Friday, May 29, 2026 91 FR 31896
- Advisory Committee; Psychopharmacologic Drugs Advisory Committee; Renewal Friday, May 29, 2026 91 FR 32062
- Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Suturing Device for Altering Gastric Anatomy for Weight Loss Thursday, May 28, 2026 91 FR 31660
- 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 Thursday, May 28, 2026 91 FR 31681
- 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 Thursday, May 28, 2026 91 FR 31680
- Challenges and Solutions in Lot-Level Food Traceability; Public Meeting and Request for Comments Thursday, May 28, 2026 91 FR 31723
- AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information; Extension of Comment Period Thursday, May 28, 2026 91 FR 31725
- 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 Wednesday, May 27, 2026 91 FR 31462
- Advisory Committee; Pulmonary-Allergy Drugs Advisory Committee; Renewal Tuesday, May 26, 2026 91 FR 30654
- Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act Tuesday, May 26, 2026 91 FR 30659
- Advisory Committee; Drug Safety and Risk Management Advisory Committee; Renewal Tuesday, May 26, 2026 91 FR 30656
- 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. Friday, May 22, 2026 91 FR 30309
- M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP); International Council for Harmonisation; Guidance for Industry; Availability Friday, May 22, 2026 91 FR 30310
- 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 Friday, May 22, 2026 91 FR 30318
- Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability Friday, May 22, 2026 91 FR 30307
- 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 Friday, May 22, 2026 91 FR 30312
- 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 Thursday, May 21, 2026 91 FR 29969
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience/Events With Approved New Animal Drugs Thursday, May 21, 2026 91 FR 29966
- 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 Thursday, May 21, 2026 91 FR 29968
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Required Warnings for Cigarette Packages and Advertisements Thursday, May 21, 2026 91 FR 29964
- Oscar Bobo: Final Debarment Order Friday, May 15, 2026 91 FR 27962
- Modified Risk Tobacco Product Application: Renewal Applications for VLN® King and VLN® Menthol King, Cigarette Products Submitted by 22nd Century Group Inc. Wednesday, May 13, 2026 91 FR 27070
- Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting Wednesday, May 13, 2026 91 FR 27065
- Biomarker Incubator: Urinary Kidney Safety Biomarkers; Request for Information Wednesday, May 13, 2026 91 FR 27056
- Azodicarbonamide (ADA); Request for Information Wednesday, May 13, 2026 91 FR 27060
- Butylated Hydroxytoluene (BHT); Request for Information Wednesday, May 13, 2026 91 FR 27054
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; The Real Cost Campaign Outcomes Evaluation Study: Cohort 3 Wednesday, May 13, 2026 91 FR 27062
- 21st Century Cures Act: Annual Compilation of Notices of Updates From the Susceptibility Test Interpretive Criteria web page Tuesday, May 12, 2026 91 FR 25894
- Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization; Guidance for Industry; Availability Tuesday, May 12, 2026 91 FR 25892
- Drug Repurposing for Unmet Medical Needs; Request for Information Tuesday, May 12, 2026 91 FR 25897
- 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 Tuesday, May 12, 2026 91 FR 25783
- 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 Monday, May 11, 2026 91 FR 25577
- Animal Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intent To Participate Monday, May 11, 2026 91 FR 25576
- Pulmonary Tuberculosis: Developing Drugs for Treatment; Guidance for Industry; Availability Monday, May 11, 2026 91 FR 25580
- Postapproval Pregnancy Safety Studies; Guidance for Industry; Availability Monday, May 11, 2026 91 FR 25579
- Clostridioides Difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, or Prevention; Guidance for Industry; Availability Monday, May 11, 2026 91 FR 25578
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications On Medical Devices and Radiation-Emitting Products Monday, May 11, 2026 91 FR 25582
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product; AVLAYAH (tividenofusp alfa-eknm) Monday, May 11, 2026 91 FR 25582
- Determination That Leucovorin Calcium, Oral Solution, Equivalent to 60 Milligrams Base/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Friday, May 8, 2026 91 FR 25361
- Medical Devices; Obstetrical and Gynecological Devices; Classification of the External Condom for Anal Intercourse or Vaginal Intercourse Friday, May 8, 2026 91 FR 25109
- Advisory Committee; Blood Products Advisory Committee; Renewal Thursday, May 7, 2026 91 FR 24880
- Patient-Matched Guides for Orthopedic Implants; Guidance for Industry and Food and Drug Administration Staff; Availability Thursday, May 7, 2026 91 FR 24876
- Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications Thursday, May 7, 2026 91 FR 24879
- Determination That MICARDIS (Telmisartan), Tablets, 20 Milligrams and 80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Thursday, May 7, 2026 91 FR 24878
- Determination That DEXAMETHASONE (Dexamethasone) Elixir, 0.5 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Wednesday, May 6, 2026 91 FR 24548
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product; OTARMENI (lunsotogene parvec-cwha) Wednesday, May 6, 2026 91 FR 24549
- Modification of Certain Terminology in Title 21 Wednesday, May 6, 2026 91 FR 24380
- Medical Devices; Ophthalmic Devices; Classification of the Corneal Storage Medium With Preservatives Including Antifungals Wednesday, May 6, 2026 91 FR 24346
- Medical Devices; Immunology and Microbiology Devices; Classification of the Circulating Tumor Cell Enrichment Device Wednesday, May 6, 2026 91 FR 24343
- Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Preserve and Stabilize Relative Abundances of Microbial Nucleic Acids in Clinical Samples Wednesday, May 6, 2026 91 FR 24341
- Agency Information Collection Activities; Proposed Collection; Comment Request; National Youth Tobacco Survey Monday, May 4, 2026 91 FR 23995
- List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Friday, May 1, 2026 91 FR 23431
- Impacts of Patient-Focused Drug Development Meetings; Establishment of a Public Docket; Request for Information and Comments Friday, May 1, 2026 91 FR 23426
- Obesity and Drug Dosing: Clinical Pharmacology Considerations; Request for Comments Friday, May 1, 2026 91 FR 23424
- Medical Devices; Exemptions From Premarket Notification: Certain Class II Devices; Request for Comments Friday, May 1, 2026 91 FR 23427
- Medical Devices; General and Plastic Surgery Devices; Classification of the Phototherapy Device for Reducing the Appearance of Acute Post-Surgical Incisions Friday, May 1, 2026 91 FR 23357
- ChemoCentryx, Inc.; Proposal To Withdraw Approval of New Drug Application for TAVNEOS (Avacopan) Capsule, 10 Milligrams; Opportunity for a Hearing Thursday, April 30, 2026 91 FR 23278
- Determination That OZEMPIC (Semaglutide) Solution, 2 Milligrams Per 1.5 Milliliters Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Thursday, April 30, 2026 91 FR 23276
- Medical Devices; Cardiovascular Devices; Classification of the Laser-Powered Inferior Vena Cava Filter Retrieval Catheter Thursday, April 30, 2026 91 FR 23161
- Medical Devices; Neurological Devices; Classification of the Brain Temperature Measurement System Thursday, April 30, 2026 91 FR 23163
- Medical Devices; Radiology Devices; Classification of the Radiation Therapy Marking Device Thursday, April 30, 2026 91 FR 23166
- 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 Thursday, April 30, 2026 91 FR 23276
- Determination FENOGLIDE (Fenofibrate) Tablets, 40 Milligrams and 120 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Thursday, April 30, 2026 91 FR 23288
- Advisory Committee; Pharmacy Compounding Advisory Committee; Renewal Thursday, April 30, 2026 91 FR 23275
- Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Requirements for Nonclinical Laboratory Studies Thursday, April 30, 2026 91 FR 23273
- AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information Wednesday, April 29, 2026 91 FR 23100
- Advisory Committee; Anesthetic and Analgesic Drug Products Advisory Committee; Renewal Monday, April 27, 2026 91 FR 22539
- 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 Monday, April 27, 2026 91 FR 22542
- Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability Friday, April 24, 2026 91 FR 22155
- Egis Pharmaceuticals Limited, et al.; Withdrawal of Approval of Three Abbreviated New Drug Applications Friday, April 24, 2026 91 FR 22156
- Commissioner's National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for Comments; Amendment Thursday, April 23, 2026 91 FR 21822
- Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke; Established List Additions and Request for Comments Thursday, April 23, 2026 91 FR 21824
- Kimberly Schaff Kiehl: Final Debarment Order Thursday, April 23, 2026 91 FR 21823
- Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Setmelanotide Eligibility Gene Variant Detection System Wednesday, April 22, 2026 91 FR 21376
- Medical Devices; Anesthesiology Devices; Classification of the Device for Sleep Apnea Testing Based on Mandibular Movement Wednesday, April 22, 2026 91 FR 21381
- Medical Devices; Ophthalmic Devices; Classification of the Digital Therapy Device for Amblyopia Wednesday, April 22, 2026 91 FR 21383
- Medical Devices; Immunology and Microbiology Devices; Classification of the Alzheimer's Disease Pathology Assessment Test Wednesday, April 22, 2026 91 FR 21379
- Establishing Impurity Specifications for Antibiotics; Draft Guidance for Industry; Availability Monday, April 20, 2026 91 FR 21000
- Potential New Indication for Testosterone Replacement Therapy Monday, April 20, 2026 91 FR 21002
- 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 Monday, April 20, 2026 91 FR 21003
- Authorization of Emergency Use for Four Animal Drugs for the Treatment of New World Screwworm; Availability Friday, April 17, 2026 91 FR 20661
- Agency Information Collection Activities; Proposed Collection; Comment Request; Radioactive Drug Research Committees Friday, April 17, 2026 91 FR 20659
- 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 Friday, April 17, 2026 91 FR 20693
- Animal Drug User Fee Act; Public Meeting; Request for Comments Friday, April 17, 2026 91 FR 20695
- Animal Generic Drug User Fee Act; Public Meeting; Request for Comments Friday, April 17, 2026 91 FR 20691
- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address Thursday, April 16, 2026 91 FR 20337
- Determination That REVIA (Naltrexone Hydrochloride) Tablets, 50 Milligrams Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Thursday, April 16, 2026 91 FR 20471
- Determination That CHEWTADZY (Tadalafil) Chewable Tablets, 5 Milligrams, 10 Milligrams, 20 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Thursday, April 16, 2026 91 FR 20464
- Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs Thursday, April 16, 2026 91 FR 20460
- Determination of Regulatory Review Period for Purposes of Patent Extension; UNLOXCYT Thursday, April 16, 2026 91 FR 20467
- Agency Information Collection Activities; Proposed Collection; Comment Request; Importation of Prescription Drugs Thursday, April 16, 2026 91 FR 20462
- 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 Thursday, April 16, 2026 91 FR 20469
- Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; MNEXSPIKE (COVID-19 Vaccine, mRNA) Thursday, April 16, 2026 91 FR 20472
- Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; MRESVIA (Respiratory Syncytial Virus Vaccine) Thursday, April 16, 2026 91 FR 20471
- Notice of Approval of Product Under Priority Review Voucher; Material Threat Medical Countermeasure Priority Review Voucher; MRESVIA (Respiratory Syncytial Virus Vaccine) Thursday, April 16, 2026 91 FR 20467
- Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) Thursday, April 16, 2026 91 FR 20460
- Medical Devices; Orthopedic Devices; Classification of the Manual Surgical Instrument for Appropriate Patient Selection for Orthopedic Implant Thursday, April 16, 2026 91 FR 20350
- Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Thursday, April 16, 2026 91 FR 20352
- Medical Devices; Ear, Nose, and Throat Devices; Classification of the Transcutaneous Electrical Nerve Stimulator for the Relief of Congestion Thursday, April 16, 2026 91 FR 20348
- 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 Thursday, April 16, 2026 91 FR 20465
- Increasing Access to Nonprescription Drugs; Public Meeting; Request for Comments Wednesday, April 15, 2026 91 FR 20170
- Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability Wednesday, April 15, 2026 91 FR 20173
- 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 Wednesday, April 15, 2026 91 FR 20171
- Determination That BILTRICIDE (Praziquantel) Oral Tablet, 600 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Monday, April 13, 2026 91 FR 18866
- Agency Information Collection Activities; Proposed Collection; Comment Request; Color Additive Certification Friday, April 10, 2026 91 FR 18464
- 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 Friday, April 10, 2026 91 FR 18466
- GlaxoSmithKline; Withdrawal of Approval of a New Drug Application for Wellcovorin (Leucovorin Calcium) Tablets, EQ 5 mg Base and EQ 25 mg Base Friday, April 10, 2026 91 FR 18472
- Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices Friday, April 10, 2026 91 FR 18468
- Determination of Regulatory Review Period for Purposes of Patent Extension; INJECTAFER Friday, April 3, 2026 91 FR 16954
- Agency Information Collection Activities; Proposed Collection; Comment Request; Customer/Partner Customer Service Satisfaction Surveys Friday, April 3, 2026 91 FR 16951
- Determination of Regulatory Review Period for Purposes of Patent Extension; HYMPAVZI Friday, April 3, 2026 91 FR 16956
- Determination of Regulatory Review Period for Purposes of Patent Extension; EMRELIS Friday, April 3, 2026 91 FR 16949
- Determination of Regulatory Review Period for Purposes of Patent Extension; ENFLONSIA Friday, April 3, 2026 91 FR 16959
- Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY Friday, April 3, 2026 91 FR 16952
- Determination of Regulatory Review Period for Purposes of Patent Extension; ENCELTO Friday, April 3, 2026 91 FR 16957
- Determination of Regulatory Review Period for Purposes of Patent Extension; ZIIHERA Friday, April 3, 2026 91 FR 16960
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product; KRESLADI (marnetegragene autotemcel) Thursday, April 2, 2026 91 FR 16714
- Notice of Decision on a Hearing Request Regarding a Proposal To Refuse To Approve a New Drug Application for TRADIPITANT Capsules Tuesday, March 31, 2026 91 FR 16007
- Advancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products; Request for Information and Comments Tuesday, March 31, 2026 91 FR 16006
- Listing of Color Additive Exempt From Certification; Spirulina Extract; Delay of Effective Date Tuesday, March 24, 2026 91 FR 13966
- Listing of Color Additive Exempt From Certification; Beetroot Red; Delay of Effective Date Tuesday, March 24, 2026 91 FR 13965
- Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Advisory Committees Monday, March 23, 2026 91 FR 13852
- Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Associated With Animal Drug and Animal Generic Drug User Fees Monday, March 23, 2026 91 FR 13854
- Commissioner's National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for Comments Monday, March 23, 2026 91 FR 13849
- General Considerations for the Use of New Approach Methodologies in Drug Development; Draft Guidance for Industry; Availability Thursday, March 19, 2026 91 FR 13313
- Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notifications Submission Thursday, March 19, 2026 91 FR 13310
- Medical Devices; Radiology Devices; Classification of Blood Irradiators Wednesday, March 18, 2026 91 FR 12951
- Over-the-Counter Monograph Drug Facility Fee Rates for Fiscal Year 2026 Wednesday, March 18, 2026 91 FR 13034
- Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications-Considerations Related to Youth Risk; Draft Guidance for Industry; Availability Wednesday, March 11, 2026 91 FR 11980
- Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry; Availability Monday, March 9, 2026 91 FR 11325
- Aspen Global Inc. c/o Lachman Consultant Services, Inc., et al.; Withdrawal of Approval of 46 New Drug Applications Monday, March 9, 2026 91 FR 11321
- 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 Monday, March 9, 2026 91 FR 11323
- Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments Tuesday, March 3, 2026 91 FR 10397
- Determination of Regulatory Review Period for Purposes of Patent Extension; LIMFLOW SYSTEM Thursday, February 26, 2026 91 FR 9628
- Determination of Regulatory Review Period for Purposes of Patent Extension; MERIT MEDICAL WRAPSODY Thursday, February 26, 2026 91 FR 9621
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Wednesday, February 25, 2026 91 FR 9290
- 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. Wednesday, February 25, 2026 91 FR 9287
- Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds Wednesday, February 25, 2026 91 FR 9285
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Retailer Training Programs Wednesday, February 25, 2026 91 FR 9290
- 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 Wednesday, February 25, 2026 91 FR 9283
- Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements Tuesday, February 24, 2026 91 FR 8886
- Advisory Committee; Gastrointestinal Drugs Advisory Committee; Renewal Tuesday, February 24, 2026 91 FR 8889
- Determination That Klonopin (Clonazepam) Tablets, 0.125 Milligrams and 0.25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Monday, February 23, 2026 91 FR 8493
- 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 Monday, February 23, 2026 91 FR 8495
- Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, et al.; Withdrawal of Approval of 11 Abbreviated New Drug Applications Friday, February 20, 2026 91 FR 8242
- Questions and Answers About Requirements for Additional Traceability Records for Certain Foods; Draft Guidance for Industry; Availability Friday, February 20, 2026 91 FR 8243
- 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 Friday, February 20, 2026 91 FR 8256
- Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Minor Use and Minor Species Friday, February 20, 2026 91 FR 8253
- Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Events Associated With New Animal Drugs Friday, February 20, 2026 91 FR 8245
Recent Issues
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