Agency Archive

Food and Drug Administration

Recent Federal Register documents and issues associated with this agency.

Recent Documents

Determining Whether To Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; Availability Tuesday, August 18, 2026 91 FR 53418
Testosterone Use in Menopausal Women; Public Workshop; Request for Comments Tuesday, August 18, 2026 91 FR 53417
Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments Monday, August 17, 2026 91 FR 53205
Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer Monday, August 17, 2026 91 FR 53209
Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product Monday, August 17, 2026 91 FR 53184
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Monday, August 17, 2026 91 FR 53268
Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements Monday, August 17, 2026 91 FR 53262
Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food Monday, August 17, 2026 91 FR 53269
Determination of Regulatory Review Period for Purposes of Patent Extension; BIZENGRI Monday, August 17, 2026 91 FR 53261
Agency Information Collection Activities; Proposed Collection; Comment Request; Imports and Electronic Import Entries Monday, August 17, 2026 91 FR 53259
Type VII Veterinary Master File for Research and Development and Risk Reviews; Guidance for Industry; Availability Monday, August 17, 2026 91 FR 53257
Determination That ANSAID (Flurbiprofen) Tablets, 50 Milligrams and 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Friday, August 14, 2026 91 FR 52708
Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments Friday, August 14, 2026 91 FR 52702
Determination That LASIX (Furosemide) Tablets, 20 Milligrams, 40 Milligrams, and 80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Friday, August 14, 2026 91 FR 52702
Container Closure Systems for Human Drugs and Biological Products; Draft Guidance for Industry; Availability Friday, August 14, 2026 91 FR 52700
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 Thursday, August 13, 2026 91 FR 52307
Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Guidance for Industry; Availability Thursday, August 13, 2026 91 FR 52305
Guide To Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce; Guidance for Industry; Availability Wednesday, August 12, 2026 91 FR 52011
Reauthorization of the Generic Drug User Fee Amendments; Public Meeting; Request for Comments Tuesday, August 11, 2026 91 FR 51718
Substances Generally Recognized as Safe Tuesday, August 11, 2026 91 FR 51834
Determination That OZOBAX (Baclofen) Oral Solution, 5 Milligrams/5 Milliliters Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Monday, August 10, 2026 91 FR 51492
Determination of Regulatory Review Period for Purposes of Patent Extension; BRINSUPRI Monday, August 10, 2026 91 FR 51493
Determination of Regulatory Review Period for Purposes of Patent Extension; DAYVIGO Monday, August 10, 2026 91 FR 51494
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 Monday, August 10, 2026 91 FR 51496
Radiology Devices; Reclassification of Digital Breast Tomosynthesis System Monday, August 10, 2026 91 FR 51406
Authorization of Emergency Use of an In Vitro Diagnostic Device in Response to an Outbreak of Mpox; Availability Thursday, August 6, 2026 91 FR 50848
Medical Devices; Radiology Devices; Classification of the Fludeoxyglucose F18-Guided Radiation Therapy System Thursday, August 6, 2026 91 FR 50708
Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to their Microbiological Effects on Bacteria of Human Health Concern; Guidance for Industry; Availability Thursday, August 6, 2026 91 FR 50860
Micro-Tracers, Inc.; Response to Objections and Requests for a Public Hearing Wednesday, August 5, 2026 91 FR 50475
Establishment of a Quantitative Medicine Innovation Network: Scope, Feasibility, and Opportunities; Request for Information Wednesday, August 5, 2026 91 FR 50553
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Advisory Committees Wednesday, August 5, 2026 91 FR 50555
Modification of Certain Terminology in Title 21; Reopening of the Comment Period Monday, August 3, 2026 91 FR 48785
Ricardo Andres Acuna: Final Debarment Order Monday, August 3, 2026 91 FR 48877
Angela Anatilde Baquero: Final Debarment Order Monday, August 3, 2026 91 FR 48875
Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Draft Guidance for Industry; Availability Monday, August 3, 2026 91 FR 48880
Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs; Guidance for Industry; Availability Monday, August 3, 2026 91 FR 48879
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Revised Draft Guidance for Industry; Availability Monday, August 3, 2026 91 FR 48882
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
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; LOARGYS (pegzilarginase-nbln) Tuesday, April 7, 2026 91 FR 17660
Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Practices and Procedures; Formal Hearings Tuesday, April 7, 2026 91 FR 17658
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

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