Agency Archive

Food and Drug Administration

Recent Federal Register documents and issues associated with this agency.

Recent Documents

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Sulfate (Protamine Sulfate) Intravenous; Solution, 50 Milligrams/5 Milliliters, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Monday, June 8, 2026 91 FR 34634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
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
Agency Information Collection Activities; Proposed Collection; Comment Request; Approved Organizations for Wholesale Drug Distributors and Third-Party Logistics Providers Friday, February 20, 2026 91 FR 8247
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 Friday, February 20, 2026 91 FR 8251
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 Friday, February 20, 2026 91 FR 8249
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 Thursday, February 19, 2026 91 FR 7825
Revocation of Methods of Analysis Regulation Thursday, February 19, 2026 91 FR 7829
Sherri Insprucker: Final Debarment Order Thursday, February 19, 2026 91 FR 8001
Justin Insprucker: Final Debarment Order Thursday, February 19, 2026 91 FR 8006
Sherrie R. McCain: Final Debarment Order Thursday, February 19, 2026 91 FR 8003
Revocation of Authorization of Emergency Use of ExThera Medical Corporation Seraph 100 Microbind Affinity Blood Filter (Seraph 100); Availability Thursday, February 19, 2026 91 FR 8008
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 Thursday, February 12, 2026 91 FR 6648
Jeremy Spencer Brown: Final Debarment Order Thursday, February 12, 2026 91 FR 6643
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments Friday, February 6, 2026 91 FR 5485
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address Friday, February 6, 2026 91 FR 5299
Determination of Regulatory Review Period for Purposes of Patent Extension; RYZNEUTA Tuesday, January 27, 2026 91 FR 3513
Determination of Regulatory Review Period for Purposes of Patent Extension; EXBLIFEP Tuesday, January 27, 2026 91 FR 3518
Determination of Regulatory Review Period for Purposes of Patent Extension; REZDIFFRA Tuesday, January 27, 2026 91 FR 3507
Determination of Regulatory Review Period for Purposes of Patent Extension; BIMZELX Tuesday, January 27, 2026 91 FR 3515
Agency Information Collection Activities; Proposed Collection; Comment Request; Medication Guides for Prescription Drug Products Tuesday, January 27, 2026 91 FR 3511
Determination of Regulatory Review Period for Purposes of Patent Extension; IMAAVY Tuesday, January 27, 2026 91 FR 3517
Determination of Regulatory Review Period for Purposes of Patent Extension; Symplicity Spyral Renal Denervation System Tuesday, January 27, 2026 91 FR 3510
FDA Records Access Authority for Cosmetics; Draft Guidance for Industry; Availability Thursday, January 22, 2026 91 FR 2779
Labeling and Preventing Cross-Contact of Gluten for Packaged Foods; Request for Information Thursday, January 22, 2026 91 FR 2781
Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; RHAPSIDO (Remibrutinib) Wednesday, January 21, 2026 91 FR 2537
M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality; International Council for Harmonisation; Draft Guidance for Industry; Availability Wednesday, January 21, 2026 91 FR 2539
Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability Wednesday, January 21, 2026 91 FR 2541
Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints To Support Accelerated Approval; Draft Guidance for Industry; Availability Wednesday, January 21, 2026 91 FR 2537
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; KYGEVVI (Doxecitine and Doxribtimine) Wednesday, January 21, 2026 91 FR 2536
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Warning Plans for Certain Tobacco Products Friday, January 16, 2026 91 FR 2135
Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products; Draft Guidance for Industry; Availability Monday, January 12, 2026 91 FR 1190
Determination of Regulatory Review Period for Purposes of Patent Extension; ZURZUVAE Tuesday, January 6, 2026 91 FR 375
Determination of Regulatory Review Period for Purposes of Patent Extension; AUGTYRO Monday, January 5, 2026 91 FR 277
Determination of Regulatory Review Period for Purposes of Patent Extension; BRENZAVVY Monday, January 5, 2026 91 FR 279
Determination of Regulatory Review Period for Purposes of Patent Extension; MEDIBEACON Monday, January 5, 2026 91 FR 282
Determination of Regulatory Review Period for Purposes of Patent Extension; IZERVAY Monday, January 5, 2026 91 FR 280
Determination That MYSOLINE (Primidone) Suspension, 250 Milligrams/5 Milliliters, Was Withdrawn From Sale for Reasons of Safety or Effectiveness Friday, January 2, 2026 91 FR 148
Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability Friday, January 2, 2026 91 FR 145
Authorization of Emergency Use for Two Animal Drugs for the Treatment of New World Screwworm; Availability Monday, December 29, 2025 90 FR 60701
Egis Pharmaceuticals Limited, et.al.; Proposal To Withdraw Approval of Three Abbreviated New Drug Applications; Opportunity for a Hearing Monday, December 29, 2025 90 FR 60724
Determination of Regulatory Review Period for Purposes of Patent Extension; ZELSUVMI Monday, December 29, 2025 90 FR 60700
Determination of Regulatory Review Period for Purposes of Patent Extension; OJEMDA Monday, December 29, 2025 90 FR 60722
Determination of Regulatory Review Period for Purposes of Patent Extension; LEQEMBI Monday, December 29, 2025 90 FR 60717
Determination of Regulatory Review Period for Purposes of Patent Extension; ADZYNMA Monday, December 29, 2025 90 FR 60727
Determination of Regulatory Review Period for Purposes of Patent Extension; ALHEMO Monday, December 29, 2025 90 FR 60729
Determination of Regulatory Review Period for Purposes of Patent Extension; ROMVIMZA Monday, December 29, 2025 90 FR 60721
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practices for Positron Emission Tomography Drugs Monday, December 29, 2025 90 FR 60726
Over-the-Counter Monograph Drug User Fee Amendments-OTC Monograph Order Request Fee Rates for Fiscal Year 2026 Monday, December 29, 2025 90 FR 60719
Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products; Notice of Meeting; Establishment of a Public Docket; Request for Comments Monday, December 29, 2025 90 FR 60715
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Friday, December 19, 2025 90 FR 59529
Agency Information Collection Activities; Proposed Collection; Comment Request; Required Warnings for Cigarette Packages and Advertisements Friday, December 19, 2025 90 FR 59533
Determination That DEXCHLORPHENIRAMINE MALEATE (Dexchlorpheniramine Maleate, Oral Syrup, 2 Milligrams/5 Milliliters) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Friday, December 19, 2025 90 FR 59530
Medical Devices; Neurological Devices; Classification of the Electrical Tongue Nerve Stimulator To Treat Motor Deficits Friday, December 19, 2025 90 FR 59377
Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) Friday, December 19, 2025 90 FR 59532
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; FORZINITY (Elamipretide) Friday, December 19, 2025 90 FR 59530
Determination That EFFEXOR XR (Venlafaxine Hydrochloride) Extended-Release Capsule, 100 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Friday, December 19, 2025 90 FR 59528
Processes and Practices Applicable to Bioresearch Monitoring Inspections; Guidance for Industry; Availability Friday, December 19, 2025 90 FR 59531
Sponsor Responsibilities-Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Bioequivalence Studies; Guidance for Industry; Availability Tuesday, December 16, 2025 90 FR 58250
Investigator Responsibilities-Safety Reporting for Investigational Drugs and Devices; Guidance for Investigators, Industry, and Institutional Review Boards; Availability Tuesday, December 16, 2025 90 FR 58249
Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Availability Wednesday, December 10, 2025 90 FR 57203
Determination of Regulatory Review Period for Purposes of Patent Extension; GRAFAPEX Wednesday, December 10, 2025 90 FR 57202
Determination of Regulatory Review Period for Purposes of Patent Extension; FILSUVEZ Wednesday, December 10, 2025 90 FR 57200
Product-Specific Guidance on Estradiol; Draft Guidance for Industry; Availability Monday, December 8, 2025 90 FR 56772
Revocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability Monday, December 8, 2025 90 FR 56770
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability Friday, December 5, 2025 90 FR 56161
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Center for Devices and Radiological Health Appeals Processes Friday, November 28, 2025 90 FR 54695
Green Innovation GmbH; Filing of Food Additive Petition (Animal Use) Wednesday, November 26, 2025 90 FR 54245
Cross-Center Master Files: Where To Submit; Draft Guidance for Industry; Availability Wednesday, November 26, 2025 90 FR 54330
Medical Devices; Neurological Devices; Classification of Field Generator Positioning Device Wednesday, November 26, 2025 90 FR 54232
Medical Devices; Gastroenterology-Urology Devices; Classification of the Anchored Esophageal Sheath Wednesday, November 26, 2025 90 FR 54230
Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use; Guidance for Industry; Availability Monday, November 17, 2025 90 FR 51373
Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers; Guidance for Industry; Availability Monday, November 17, 2025 90 FR 51369
Menstrual Products-Performance Testing and Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Monday, November 17, 2025 90 FR 51371
Quality Management System Information for Certain Premarket Submission Reviews; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Monday, November 17, 2025 90 FR 51374
E20 Adaptive Designs for Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; Availability Tuesday, September 30, 2025 90 FR 46900
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mitigation Strategies To Protect Food Against Intentional Adulteration Monday, September 29, 2025 90 FR 46610
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United States Monday, September 29, 2025 90 FR 46609
Revocation of Food Standards for 11 Products Not Currently Sold; Confirmation of Effective Date Friday, September 26, 2025 90 FR 46348
Prior Notice: Adding Requirement To Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe for Post-Refusal and Post-Hold Submissions Thursday, September 25, 2025 90 FR 46045
Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry; Availability Thursday, September 25, 2025 90 FR 46225

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