| Closes | Document |
|---|
closed 1 day ago
Oct 16, 2026 | Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments
Proposed Rule · published Aug 17, 2026 · FDA-2025-N-6224
Medical devices |
closed 1 day ago
Oct 16, 2026 | Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer
Proposed Rule · published Aug 17, 2026 · FDA-2026-N-8249
Medical devices |
closed 1 day ago
Oct 16, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; BIZENGRI
Notice · published Aug 17, 2026 · FDA-2025-E-0485, FDA-2025-E-0486, FDA-2025-E-0488, FDA-2025-E-0489, FDA-2025-E-0490
Vaccines / biologics |
closed 1 day ago
Oct 16, 2026 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing
Notice · published Sep 16, 2026 · FDA-2026-N-0027
Vaccines / biologics |
closed 1 day ago
Oct 16, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food
Notice · published Aug 17, 2026 · FDA-2026-N-7757
Food & dietary supplements |
closed 1 day ago
Oct 16, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Imports and Electronic Import Entries
Notice · published Aug 17, 2026 · FDA-2026-N-8328
Other FDA topics |
closed 3 days ago
Oct 14, 2026 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Customer/Partner Customer Service Satisfaction Surveys
Notice · published Sep 14, 2026 · FDA-2026-N-2740
Other FDA topics |
closed 4 days ago
Oct 13, 2026 | Container Closure Systems for Human Drugs and Biological Products; Draft Guidance for Industry; Availability
Notice · published Aug 14, 2026 · FDA-2026-D-7957
CMC (chemistry, manufacturing & controls) Medical devices |
closed 4 days ago
Oct 13, 2026 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed
Notice · published Sep 11, 2026 · FDA-2026-N-2917
Food & dietary supplements |
closed 8 days ago
Oct 9, 2026 | Radiology Devices; Reclassification of Digital Breast Tomosynthesis System
Proposed Rule · published Aug 10, 2026 · FDA-2026-N-7630
Medical devices |
closed 15 days ago
Oct 2, 2026 | Modification of Certain Terminology in Title 21; Reopening of the Comment Period
Proposed Rule · published Aug 3, 2026 · FDA-2026-N-2886
Clinical Vaccines / biologics Medical devices Food & dietary supplements Tobacco |
closed 15 days ago
Oct 2, 2026 | Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Draft Guidance for Industry; Availability
Notice · published Aug 3, 2026 · FDA-2026-D-4272
CMC (chemistry, manufacturing & controls) Vaccines / biologics Medical devices |
closed 15 days ago
Oct 2, 2026 | Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Revised Draft Guidance for Industry; Availability
Notice · published Aug 3, 2026 · FDA-2018-D-3546
Other FDA topics |
closed 16 days ago
Oct 1, 2026 | Electronic Submission of Postmarketing Individual Case Safety Reports to the Food and Drug Administration Adverse Event Monitoring System Using International Council of Harmonisation E2B(R3) Data Standards; Regional Data Elements and Implementation Schedule
Notice · published Apr 6, 2026 · FDA-2016-D-1280
CMC (chemistry, manufacturing & controls) Vaccines / biologics |
closed 16 days ago
Oct 1, 2026 | Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2027
Notice · published Jul 30, 2026 · FDA-2026-N-7498
Other FDA topics |
closed 16 days ago
Oct 1, 2026 | Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2027
Notice · published Jul 30, 2026 · FDA-2026-N-7558
Other FDA topics |
closed 17 days ago
Sep 30, 2026 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Potential Tobacco Product Violations Reporting Form
Notice · published Aug 31, 2026 · FDA-2026-N-6540
Tobacco |
closed 19 days ago
Sep 28, 2026 | Product-Specific Guidances; Revised Draft Guidances for Industry; Availability
Notice · published Jul 29, 2026 · FDA-2007-D-0369
CMC (chemistry, manufacturing & controls) |
closed 19 days ago
Sep 28, 2026 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Associated With Animal Drug and Animal Generic Drug User Fees
Notice · published Aug 28, 2026 · FDA-2026-N-2365
Other FDA topics |
closed 19 days ago
Sep 28, 2026 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Importation of Prescription Drugs
Notice · published Aug 28, 2026 · FDA-2026-N-3240
Other FDA topics |
closed 19 days ago
Sep 28, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Expanded Access to Investigational Drugs for Treatment Use
Notice · published Jul 28, 2026 · FDA-2026-N-7426
Other FDA topics |
closed 25 days ago
Sep 22, 2026 | Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Revised Draft Guidance for Industry; Availability
Notice · published Jun 24, 2026 · FDA-2019-D-4964
Clinical Vaccines / biologics |
closed 29 days ago
Sep 18, 2026 | International Association of Color Manufacturers; Filing of Color Additive Petition
Proposed Rule · published Aug 19, 2026 · FDA-2026-C-8883
Food & dietary supplements |
closed 29 days ago
Sep 18, 2026 | Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate
Rule · published Aug 19, 2026 · FDA-2017-F-4399
Food & dietary supplements |
closed 31 days ago
Sep 16, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements
Notice · published Aug 17, 2026 · FDA-2026-N-1736
Clinical |
closed 32 days ago
Sep 15, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary National Retail Food Regulatory Program Standards
Notice · published Jul 17, 2026 · FDA-2026-N-7338
Food & dietary supplements |
closed 32 days ago
Sep 15, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Cosmetic Products
Notice · published Jul 17, 2026 · FDA-2026-N-6739
Other FDA topics |
closed 32 days ago
Sep 15, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Voluntary Improvement Program
Notice · published Jul 17, 2026 · FDA-2026-N-6876
Medical devices |
closed 32 days ago
Sep 15, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements
Notice · published Jul 17, 2026 · FDA-2026-N-7131
Food & dietary supplements |
closed 32 days ago
Sep 15, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Devices: (Medical Product Safety Network (MedSun))
Notice · published Jul 17, 2026 · FDA-2026-N-7129
Medical devices |
closed 32 days ago
Sep 15, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Accreditation Scheme for Conformity Assessment Program
Notice · published Jul 17, 2026 · FDA-2026-N-7130
Other FDA topics |
closed 33 days ago
Sep 14, 2026 | Establishment Registration and Product Listing for Tobacco Products
Proposed Rule · published Jun 29, 2026 · FDA-2025-N-7130
GMP / manufacturing Tobacco |
closed 36 days ago
Sep 11, 2026 | Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
Proposed Rule · published Jul 13, 2026 · FDA-2025-N-6075
GMP / manufacturing |
closed 43 days ago
Sep 4, 2026 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Advisory Committees
Notice · published Aug 5, 2026 · FDA-2026-N-2364
Other FDA topics |
closed 43 days ago
Sep 4, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Biologics License Applications, Procedures and Requirements
Notice · published Jul 6, 2026 · FDA-2026-N-6667
Vaccines / biologics |
closed 44 days ago
Sep 3, 2026 | International Drug Scheduling; Single Convention on Narcotic Drugs; Convention on Psychotropic Substances; Clobromazolam (Phenazolam); Cychlorphine (N-Propionitrile Chlorphine); Desalkylgidazepam (Bromonordiazepam); Ethylbromazolam; Etomethazene (5-Methyl Etodesnitazene); Spirochlorphine (R6980); Etomidate; Medetomidine; Request for Comments
Notice · published Aug 26, 2026 · FDA-2026-N-9208
Other FDA topics |
closed 46 days ago
Sep 1, 2026 | Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry; Availability
Notice · published Jun 3, 2026 · FDA-2026-D-1257
Vaccines / biologics |
closed 52 days ago
Aug 26, 2026 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees
Notice · published Jul 27, 2026 · FDA-2026-N-3099
Other FDA topics |
closed 53 days ago
Aug 25, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Time and Extent Applications for Nonprescription Drug Products
Notice · published Jun 26, 2026 · FDA-2026-N-5827, FDA_FRDOC_0001
Other FDA topics |
closed 54 days ago
Aug 24, 2026 | Proposal To Revoke the Color Additive Listing for Use of Citrus Red No. 2 on the Skins of Mature Oranges
Proposed Rule · published Jul 23, 2026 · FDA-2026-N-6304
Food & dietary supplements |
closed 54 days ago
Aug 24, 2026 | Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Availability
Notice · published Jun 24, 2026 · FDA-2023-D-5259
Other FDA topics |
closed 54 days ago
Aug 24, 2026 | Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 066
Notice · published Aug 24, 2026 · FDA-2004-N-0451
Medical devices |
closed 54 days ago
Aug 24, 2026 | Expedited Investigational New Drug Pilot Program; Request for Information; Extension of the Comment Period
Notice · published Jul 21, 2026 · FDA-2026-N-4699
Clinical |
closed 54 days ago
Aug 24, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Potential Tobacco Product Violations Reporting Form
Notice · published Jun 23, 2026 · FDA-2026-N-6540
Tobacco |
closed 57 days ago
Aug 21, 2026 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notifications Submission
Notice · published Jul 22, 2026 · FDA-2026-N-1849
Medical devices |
closed 61 days ago
Aug 17, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals
Notice · published Jun 18, 2026 · FDA-2026-N-5829
Other FDA topics |
closed 64 days ago
Aug 14, 2026 | Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability
Notice · published Jun 15, 2026 · FDA-2026-D-2698
Other FDA topics |
closed 73 days ago
Aug 5, 2026 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Approval of Medical Devices
Notice · published Jul 6, 2026 · FDA-2026-N-2915
Medical devices |
closed 73 days ago
Aug 5, 2026 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Practices and Procedures; Formal Hearings
Notice · published Jul 6, 2026 · FDA-2026-N-2431
Other FDA topics |
closed 75 days ago
Aug 3, 2026 | Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability
Notice · published Jun 3, 2026 · FDA-2016-D-1307
Medical devices |
closed 78 days ago
Jul 31, 2026 | Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability
Notice · published Jun 1, 2026 · FDA-2026-D-2839
Vaccines / biologics |
closed 78 days ago
Jul 31, 2026 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medication Guides for Prescription Drug Products
Notice · published Jul 1, 2026 · FDA-2025-N-6869
Other FDA topics |
closed 80 days ago
Jul 29, 2026 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Minor Use and Minor Species
Notice · published Jun 29, 2026 · FDA-2026-N-1305
Other FDA topics |
closed 82 days ago
Jul 27, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
Notice · published May 26, 2026 · FDA-2026-N-5128
GMP / manufacturing |
closed 85 days ago
Jul 24, 2026 | 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
Notice · published Jun 24, 2026 · FDA-2026-D-6539
Vaccines / biologics |
closed 86 days ago
Jul 23, 2026 | 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
Notice · published Apr 15, 2026 · FDA-2026-N-3273
Vaccines / biologics |
closed 86 days ago
Jul 23, 2026 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification of Identity, Form FDA 3975
Notice · published Jun 23, 2026 · FDA-2025-N-1732
Other FDA topics |
closed 87 days ago
Jul 22, 2026 | Expedited Investigational New Drug Pilot Program; Request for Information
Notice · published Jun 24, 2026 · FDA-2026-N-4699
Clinical |
closed 88 days ago
Jul 21, 2026 | Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Notice · published May 22, 2026 · FDA-2007-D-0369
CMC (chemistry, manufacturing & controls) |
closed 89 days ago
Jul 20, 2026 | 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
Notice · published Jun 18, 2026 · FDA-2026-N-0686
GMP / manufacturing Food & dietary supplements |
closed 89 days ago
Jul 20, 2026 | 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
Notice · published Jun 18, 2026 · FDA-2026-N-0496
GMP / manufacturing |
closed 94 days ago
Jul 15, 2026 | Challenges and Solutions in Lot-Level Food Traceability; Public Meeting and Request for Comments
Notice · published May 28, 2026 · FDA-2014-N-0053
Food & dietary supplements |
closed 95 days ago
Jul 14, 2026 | Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability
Notice · published Apr 15, 2026 · FDA-2026-D-1255
Clinical Vaccines / biologics |
closed 96 days ago
Jul 13, 2026 | Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments; Reopening of the Comment Period
Notice · published Jun 11, 2026 · FDA-2026-N-0809
CMC (chemistry, manufacturing & controls) |
closed 96 days ago
Jul 13, 2026 | Drug Repurposing for Unmet Medical Needs; Request for Information; Extension of Comment Period
Notice · published Jun 11, 2026 · FDA-2026-N-4492
Other FDA topics |
closed 96 days ago
Jul 13, 2026 | Butylated Hydroxytoluene (BHT); Request for Information
Notice · published May 13, 2026 · FDA-2026-N-2526
Food & dietary supplements |
closed 96 days ago
Jul 13, 2026 | Biomarker Incubator: Urinary Kidney Safety Biomarkers; Request for Information
Notice · published May 13, 2026 · FDA-2026-N-0005
Other FDA topics |
closed 96 days ago
Jul 13, 2026 | Azodicarbonamide (ADA); Request for Information
Notice · published May 13, 2026 · FDA-2026-N-4126
Food & dietary supplements |
closed 96 days ago
Jul 13, 2026 | 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
Notice · published Jun 11, 2026 · FDA-2026-N-0498
Food & dietary supplements |
closed 96 days ago
Jul 13, 2026 | 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
Notice · published Jun 11, 2026 · FDA-2025-N-4250
Food & dietary supplements |
closed 96 days ago
Jul 13, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting
Notice · published May 13, 2026 · FDA-2026-N-3098
Other FDA topics |
closed 99 days ago
Jul 10, 2026 | Fiscal Year 2026 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments
Notice · published Feb 27, 2026 · FDA-2023-N-0119
Other FDA topics |
closed 103 days ago
Jul 6, 2026 | Modification of Certain Terminology in Title 21
Proposed Rule · published May 6, 2026 · FDA-2026-N-2886
Clinical Vaccines / biologics Medical devices Food & dietary supplements Tobacco |
closed 103 days ago
Jul 6, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; National Youth Tobacco Survey
Notice · published May 4, 2026 · FDA-2026-N-3070
Tobacco |
closed 109 days ago
Jun 30, 2026 | Obesity and Drug Dosing: Clinical Pharmacology Considerations; Request for Comments
Notice · published May 1, 2026 · FDA-2026-N-3499
Other FDA topics |
closed 109 days ago
Jun 30, 2026 | Medical Devices; Exemptions From Premarket Notification: Certain Class II Devices; Request for Comments
Notice · published May 1, 2026 · FDA-2026-N-4268
Medical devices |
closed 109 days ago
Jun 30, 2026 | List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Notice · published May 1, 2026 · FDA-2018-N-3240
GMP / manufacturing |
closed 109 days ago
Jun 30, 2026 | Impacts of Patient-Focused Drug Development Meetings; Establishment of a Public Docket; Request for Information and Comments
Notice · published May 1, 2026 · FDA-2026-N-3947
Other FDA topics |
closed 110 days ago
Jun 29, 2026 | 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
Proposed Rule · published May 28, 2026 · FDA-2023-F-5684
Food & dietary supplements |
closed 110 days ago
Jun 29, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; ZELSUVMI
Notice · published Dec 29, 2025 · FDA-2024-E-1293
Other FDA topics |
closed 110 days ago
Jun 29, 2026 | 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
Proposed Rule · published May 28, 2026 · FDA-2023-C-5679
Food & dietary supplements |
closed 110 days ago
Jun 29, 2026 | ChemoCentryx, Inc.; Proposal To Withdraw Approval of New Drug Application for TAVNEOS (Avacopan) Capsule, 10 Milligrams; Opportunity for a Hearing
Notice · published Apr 30, 2026 · FDA-2026-N-1321
Other FDA topics |
closed 110 days ago
Jun 29, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Requirements for Nonclinical Laboratory Studies
Notice · published Apr 30, 2026 · FDA-2026-N-3532
Other FDA topics |
closed 110 days ago
Jun 29, 2026 | AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information; Extension of Comment Period
Notice · published May 28, 2026 · FDA-2026-N-4390
Clinical |
closed 117 days ago
Jun 22, 2026 | Establishing Impurity Specifications for Antibiotics; Draft Guidance for Industry; Availability
Notice · published Apr 20, 2026 · FDA-2025-D-6130
CMC (chemistry, manufacturing & controls) |
closed 117 days ago
Jun 22, 2026 | 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
Notice · published Apr 20, 2026 · FDA-2025-D-7121
Medical devices |
closed 117 days ago
Jun 22, 2026 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Required Warnings for Cigarette Packages and Advertisements
Notice · published May 21, 2026 · FDA-2025-N-6076
Tobacco |
closed 117 days ago
Jun 22, 2026 | 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
Notice · published May 21, 2026 · FDA-2026-N-0497
Other FDA topics |
closed 117 days ago
Jun 22, 2026 | 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
Notice · published May 21, 2026 · FDA-2026-N-0746
GMP / manufacturing |
closed 117 days ago
Jun 22, 2026 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience/Events With Approved New Animal Drugs
Notice · published May 21, 2026 · FDA-2026-N-1303
Other FDA topics |
closed 123 days ago
Jun 16, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Radioactive Drug Research Committees
Notice · published Apr 17, 2026 · FDA-2026-N-3099
Other FDA topics |
closed 123 days ago
Jun 16, 2026 | 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
Notice · published Apr 17, 2026 · FDA-2026-N-2917
Food & dietary supplements |
closed 124 days ago
Jun 15, 2026 | 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
Notice · published Apr 16, 2026 · FDA-2021-D-0613
CMC (chemistry, manufacturing & controls) Food & dietary supplements |
closed 124 days ago
Jun 15, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; UNLOXCYT
Notice · published Apr 16, 2026 · FDA-2025-E-0501, FDA-2025-E-0502
Vaccines / biologics |
closed 124 days ago
Jun 15, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs
Notice · published Apr 16, 2026 · FDA-2026-N-3400
Other FDA topics |
closed 124 days ago
Jun 15, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Importation of Prescription Drugs
Notice · published Apr 16, 2026 · FDA-2026-N-3240
Other FDA topics |
closed 127 days ago
Jun 12, 2026 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; The Real Cost Campaign Outcomes Evaluation Study: Cohort 3
Notice · published May 13, 2026 · FDA-2025-N-1600
Other FDA topics |
closed 128 days ago
Jun 11, 2026 | Drug Repurposing for Unmet Medical Needs; Request for Information
Notice · published May 12, 2026 · FDA-2026-N-4492
Other FDA topics |
closed 129 days ago
Jun 10, 2026 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications On Medical Devices and Radiation-Emitting Products
Notice · published May 11, 2026 · FDA-2025-N-2220
Medical devices |
closed 130 days ago
Jun 9, 2026 | 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
Notice · published Apr 10, 2026 · FDA-2026-N-2743
Food & dietary supplements |
closed 130 days ago
Jun 9, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices
Notice · published Apr 10, 2026 · FDA-2026-N-2915
Medical devices |
closed 130 days ago
Jun 9, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Color Additive Certification
Notice · published Apr 10, 2026 · FDA-2026-N-2742
Food & dietary supplements |
closed 131 days ago
Jun 8, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Practices and Procedures; Formal Hearings
Notice · published Apr 7, 2026 · FDA-2026-N-2431
Other FDA topics |
closed 137 days ago
Jun 2, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; ZIIHERA
Notice · published Apr 3, 2026 · FDA-2025-E-0372
Vaccines / biologics |
closed 137 days ago
Jun 2, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY
Notice · published Apr 3, 2026 · FDA-2025-E-0845, FDA-2025-E-0863, FDA-2025-E-0864, FDA-2025-E-0865, FDA-2025-E-0866, FDA-2025-E-0867, FDA-2025-E-0868, FDA-2025-E-0869, FDA-2025-E-0870, FDA-2025-E-0871, FDA-2025-E-0872
Vaccines / biologics |
closed 137 days ago
Jun 2, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; INJECTAFER
Notice · published Apr 3, 2026 · FDA-2014-E-2328
Other FDA topics |
closed 137 days ago
Jun 2, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; HYMPAVZI
Notice · published Apr 3, 2026 · FDA-2025-E-0158
Vaccines / biologics |
closed 137 days ago
Jun 2, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; ENFLONSIA
Notice · published Apr 3, 2026 · FDA-2025-E-3626
Vaccines / biologics |
closed 137 days ago
Jun 2, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; ENCELTO
Notice · published Apr 3, 2026 · FDA-2025-E-1672
Vaccines / biologics |
closed 137 days ago
Jun 2, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; EMRELIS
Notice · published Apr 3, 2026 · FDA-2025-E-3073, FDA-2025-E-3074
Vaccines / biologics |
closed 137 days ago
Jun 2, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Customer/Partner Customer Service Satisfaction Surveys
Notice · published Apr 3, 2026 · FDA-2026-N-2740
Other FDA topics |
closed 138 days ago
Jun 1, 2026 | Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments
Notice · published Mar 3, 2026 · FDA-2026-N-0809
CMC (chemistry, manufacturing & controls) |
closed 138 days ago
Jun 1, 2026 | Filing of Color Additive Petition From the International Association of Color Manufacturers; Request To Amend the Color Additive Regulations To Remove the Solvents Methylene Chloride, Trichloroethylene, and Ethylene Dichloride
Proposed Rule · published Apr 1, 2026 · FDA-2026-C-3071
Food & dietary supplements |
closed 138 days ago
Jun 1, 2026 | 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
Notice · published Apr 30, 2026 · FDA-2026-N-0499
Food & dietary supplements |
closed 138 days ago
Jun 1, 2026 | Advancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products; Request for Information and Comments
Notice · published Mar 31, 2026 · FDA-2026-N-2476
Clinical Vaccines / biologics |
closed 141 days ago
May 29, 2026 | Microbiology Devices; Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests
Proposed Rule · published Mar 30, 2026 · FDA-2026-N-2590
Medical devices |
closed 141 days ago
May 29, 2026 | AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information
Notice · published Apr 29, 2026 · FDA-2026-N-4390
Clinical |
closed 144 days ago
May 26, 2026 | Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke; Established List Additions and Request for Comments
Notice · published Apr 23, 2026 · FDA-2026-N-2642
Tobacco |
closed 148 days ago
May 22, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Associated With Animal Drug and Animal Generic Drug User Fees
Notice · published Mar 23, 2026 · FDA-2026-N-2365
Other FDA topics |
closed 148 days ago
May 22, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Advisory Committees
Notice · published Mar 23, 2026 · FDA-2026-N-2364
Other FDA topics |
closed 149 days ago
May 21, 2026 | Questions and Answers About Requirements for Additional Traceability Records for Certain Foods; Draft Guidance for Industry; Availability
Notice · published Feb 20, 2026 · FDA-2025-D-2837
Food & dietary supplements |
closed 152 days ago
May 18, 2026 | Preparation for International Cooperation on Cosmetics Regulation Twentieth Annual Meeting (ICCR-20); Request for Comments
Notice · published Mar 18, 2026 · FDA-2026-N-2279
Other FDA topics |
closed 152 days ago
May 18, 2026 | Medical Devices; Radiology Devices; Classification of Blood Irradiators
Proposed Rule · published Mar 18, 2026 · FDA-2025-N-5996
Vaccines / biologics Medical devices |
closed 152 days ago
May 18, 2026 | General Considerations for the Use of New Approach Methodologies in Drug Development; Draft Guidance for Industry; Availability
Notice · published Mar 19, 2026 · FDA-2025-D-6131
Clinical |
closed 152 days ago
May 18, 2026 | Effective Date of Requirement for Premarket Approval Applications for Blood Irradiators Intended To Prevent Metastasis
Proposed Rule · published Mar 18, 2026 · FDA-2025-N-5995
Vaccines / biologics Medical devices |
closed 152 days ago
May 18, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notifications Submission
Notice · published Mar 19, 2026 · FDA-2026-N-1849
Medical devices |
closed 157 days ago
May 13, 2026 | Modified Risk Tobacco Product Application: Renewal Applications for VLN® King and VLN® Menthol King, Cigarette Products Submitted by 22nd Century Group Inc.
Notice · published May 13, 2026 · FDA-2019-N-0994
Tobacco |
closed 157 days ago
May 13, 2026 | Butylated Hydroxytoluene (BHT); Request for Information; Reopening of Comment Period
Notice · published Jul 30, 2026 · FDA-2026-N-2526
Other FDA topics |
closed 158 days ago
May 12, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements
Notice · published Mar 13, 2026 · FDA-2026-N-1736
Clinical |
closed 159 days ago
May 11, 2026 | New and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act; Draft Guidance for Industry; Availability
Notice · published Mar 10, 2026 · FDA-2011-D-0611
Vaccines / biologics |
closed 159 days ago
May 11, 2026 | Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications-Considerations Related to Youth Risk; Draft Guidance for Industry; Availability
Notice · published Mar 11, 2026 · FDA-2026-D-1817
Tobacco |
closed 162 days ago
May 8, 2026 | Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry; Availability
Notice · published Mar 9, 2026 · FDA-2025-D-1504
GMP / manufacturing Vaccines / biologics |
closed 162 days ago
May 8, 2026 | Increasing Access to Nonprescription Drugs; Public Meeting; Request for Comments
Notice · published Apr 15, 2026 · FDA-2025-N-4731
Other FDA topics |
closed 165 days ago
May 5, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; ENSACOVE
Notice · published Mar 6, 2026 · FDA-2025-E-0493
Other FDA topics |
closed 166 days ago
May 4, 2026 | New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
Notice · published Mar 4, 2026 · FDA-2024-D-4388
Clinical |
closed 169 days ago
May 1, 2026 | List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period
Notice · published Jun 26, 2026 · FDA-2018-N-3240, FDA_FRDOC_0001
GMP / manufacturing |
closed 169 days ago
May 1, 2026 | Consideration of Acceptable Market Name Change for Certain Rockfish (Sebastes spp.); Request for Information
Notice · published Apr 1, 2026 · FDA-2026-N-2741
Food & dietary supplements |
closed 172 days ago
Apr 28, 2026 | Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Notice · published Feb 27, 2026 · FDA-2007-D-0369
CMC (chemistry, manufacturing & controls) |
closed 173 days ago
Apr 27, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; TRYNGOLZA
Notice · published Feb 26, 2026 · FDA-2025-E-0500
Other FDA topics |
closed 173 days ago
Apr 27, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; TEVIMBRA
Notice · published Feb 26, 2026 · FDA-2024-E-3572
Vaccines / biologics |
closed 173 days ago
Apr 27, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; REVUFORJ
Notice · published Feb 26, 2026 · FDA-2025-E-0371
Other FDA topics |
closed 173 days ago
Apr 27, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; ORLYNVAH
Notice · published Feb 26, 2026 · FDA-2025-E-0161
Other FDA topics |
closed 173 days ago
Apr 27, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; MERIT MEDICAL WRAPSODY
Notice · published Feb 26, 2026 · FDA-2025-E-1228, FDA-2025-E-1229
Medical devices |
closed 173 days ago
Apr 27, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; LIMFLOW SYSTEM
Notice · published Feb 26, 2026 · FDA-2024-E-3555, FDA-2024-E-3564, FDA-2024-E-3565
Medical devices |
closed 173 days ago
Apr 27, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; AEROPACE
Notice · published Feb 26, 2026 · FDA-2025-E-1226
Medical devices |
closed 173 days ago
Apr 27, 2026 | 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
Notice · published Feb 25, 2026 · FDA-2026-D-1256
Vaccines / biologics |
closed 173 days ago
Apr 27, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
Notice · published Feb 24, 2026 · FDA-2026-N-0686
GMP / manufacturing Food & dietary supplements |
closed 173 days ago
Apr 27, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds
Notice · published Feb 25, 2026 · FDA-2026-N-0496
GMP / manufacturing |
closed 173 days ago
Apr 27, 2026 | 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.
Notice · published Feb 25, 2026 · FDA-2026-N-0027
Vaccines / biologics |
closed 178 days ago
Apr 22, 2026 | Labeling and Preventing Cross-Contact of Gluten for Packaged Foods; Request for Information; Extension of Comment Period
Notice · published Mar 18, 2026 · FDA-2023-P-3942
Food & dietary supplements |
closed 179 days ago
Apr 21, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Minor Use and Minor Species
Notice · published Feb 20, 2026 · FDA-2026-N-1305
Other FDA topics |
closed 179 days ago
Apr 21, 2026 | 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
Notice · published Feb 20, 2026 · FDA-2026-N-0499
Food & dietary supplements |
closed 179 days ago
Apr 21, 2026 | 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
Notice · published Feb 20, 2026 · FDA-2026-N-0746
GMP / manufacturing |
closed 179 days ago
Apr 21, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Approved Organizations for Wholesale Drug Distributors and Third-Party Logistics Providers
Notice · published Feb 20, 2026 · FDA-2026-N-0684
GMP / manufacturing |
closed 179 days ago
Apr 21, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Events Associated With New Animal Drugs
Notice · published Feb 20, 2026 · FDA-2026-N-1303
Other FDA topics |
closed 180 days ago
Apr 20, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; SYMVESS
Notice · published Feb 19, 2026 · FDA-2025-E-0862
Vaccines / biologics |
closed 180 days ago
Apr 20, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe Processing and Importing of Fish and Fishery Products
Notice · published Feb 19, 2026 · FDA-2026-N-0498
Food & dietary supplements |
closed 180 days ago
Apr 20, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Patent Term Restoration; Due Diligence Petitions; Filing, Format, and Content of Petitions
Notice · published Feb 18, 2026 · FDA-2026-N-0497
Other FDA topics |