[ FDA REGULATORY CHANGES ]

What the FDA is changing — as it happens.

Live FDA rules, proposed rules, and notices from the Federal Register, tagged by regulated industry — so you can track what is changing across drug, device, food, and beyond, and never miss an open comment window.

648
Documents tracked (12 mo)
99
Rules
24
Proposed rules
33
Open for comment
latest published 2026-07-30 · source: U.S. Federal Register (FDA)
⏳ CLOSING SOONEST · OPEN FOR PUBLIC COMMENT
COMMENTS CLOSE Jul 31, 2026
Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability
COMMENTS CLOSE Jul 31, 2026
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medication Guides for Prescription Drug Products
COMMENTS CLOSE Aug 3, 2026
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability
COMMENTS CLOSE Aug 5, 2026
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Practices and Procedures; Formal Hearings
COMMENTS CLOSE Aug 5, 2026
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Approval of Medical Devices
COMMENTS CLOSE Aug 14, 2026
Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability
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681 matching documents
PublishedTypeTitleIndustryComments close
Feb 26, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; MERIT MEDICAL WRAPSODY
drugdevicefood
Apr 27, 2026
Feb 26, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; TEVIMBRA
drugbiologicsfood
Apr 27, 2026
Feb 25, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Retailer Training Programs
drugfood
Mar 27, 2026
Feb 25, 2026NoticeAgency Information Collection Activities; Announcement of Office of Management and Budget Approvals
drugfood
Feb 25, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds
drugdevicefood
Apr 27, 2026
Feb 25, 2026NoticeConsiderations 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
drugbiologicsfood
Apr 27, 2026
Feb 25, 2026NoticeAgency 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.
drugbiologicsdevice
Apr 27, 2026
Feb 24, 2026NoticeAdvisory Committee; Gastrointestinal Drugs Advisory Committee; Renewal
drugfood
Feb 24, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
drugdevicefood
Apr 27, 2026
Feb 23, 2026NoticeIssuance of Priority Review Voucher; Rare Pediatric Disease Product; WASKYRA (etuvetidigene autotemcel)
drugfoodcosmetics
Feb 23, 2026NoticeDetermination That Klonopin (Clonazepam) Tablets, 0.125 Milligrams and 0.25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
drugfood
Feb 23, 2026NoticeAgency 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
drugfoodcosmetics
Mar 25, 2026
Feb 20, 2026NoticeAgency 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
drugdevicefood
Apr 21, 2026
Feb 20, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice
drugdevicefood
Apr 21, 2026
Feb 20, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Minor Use and Minor Species
drugdevicefood
Apr 21, 2026
Feb 20, 2026NoticeMasuu Global Solutions LLC, U.S. Agent for Extrovis AG, et al.; Withdrawal of Approval of 11 Abbreviated New Drug Applications
drugfood
Feb 20, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Approved Organizations for Wholesale Drug Distributors and Third-Party Logistics Providers
drugfood
Apr 21, 2026
Feb 20, 2026NoticeQuestions and Answers About Requirements for Additional Traceability Records for Certain Foods; Draft Guidance for Industry; Availability
drugfood
May 21, 2026
Feb 20, 2026NoticeRequirements 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
drugfood
Feb 20, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Adverse Events Associated With New Animal Drugs
drugdevicefood
Apr 21, 2026
Feb 19, 2026RuleRevocation 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
drugdevicefood
Feb 19, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe Processing and Importing of Fish and Fishery Products
drugdevicefood
Apr 20, 2026
Feb 19, 2026NoticeSherrie R. McCain: Final Debarment Order
drugfoodcosmetics
Feb 19, 2026NoticeFood and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 065
drugdevicefood
Feb 19, 2026
Feb 19, 2026NoticeRevocation of Authorization of Emergency Use of ExThera Medical Corporation Seraph 100 Microbind Affinity Blood Filter (Seraph 100); Availability
drugbiologicsfood
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Data: U.S. Federal Register API (documents from the Food and Drug Administration). Industry tags are a SPEQ keyword-derived interpretation of each document, not official Federal Register metadata. Follow the title link for the authoritative document.