[ 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.

636
Documents tracked (12 mo)
99
Rules
24
Proposed rules
31
Open for comment
latest published 2026-07-29 · source: U.S. Federal Register (FDA)
⏳ CLOSING SOONEST · OPEN FOR PUBLIC COMMENT
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 Jul 31, 2026
Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability
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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability
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669 matching documents
PublishedTypeTitleIndustryComments close
Jun 24, 2026NoticeDemonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Revised Draft Guidance for Industry; Availability
drugbiologicsfood
Sep 22, 2026
Jun 24, 2026NoticeInternational Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Bovines; Guidance for Industry; Availability
drugfoodveterinary
Jun 24, 2026NoticeInternational Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Ovines; Guidance for Industry; Availability
drugfoodveterinary
Jun 24, 2026NoticeInternational Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: General Recommendations; Guidance for Industry; Availability
drugfoodveterinary
Jun 24, 2026NoticeQuantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials; Draft Guidance for Industry; Availability
drugbiologicsfood
Jul 24, 2026
Jun 24, 2026NoticeInternational Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Caprines; Guidance for Industry; Availability
drugfoodveterinary
Jun 24, 2026NoticeInternational Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Porcines; Guidance for Industry; Availability
drugfoodveterinary
Jun 24, 2026NoticeInternational Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Felines; Guidance for Industry; Availability
drugfoodveterinary
Jun 24, 2026NoticeInternational 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
drugfoodveterinary
Jun 24, 2026NoticeInternational Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Equines; Guidance for Industry; Availability
drugfoodveterinary
Jun 23, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification of Identity, Form FDA 3975
drugfood
Jul 23, 2026
Jun 23, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Potential Tobacco Product Violations Reporting Form
drugdevicefood
Aug 24, 2026
Jun 22, 2026RuleMedical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Light-Projecting Measuring Device
drugdevicefood
Jun 22, 2026NoticeEpizyme, Inc.; Withdrawal of Approval of New Drug Application for TAZVERIK (Tazemetostat) Tablet, 200 Milligrams
drugfood
Jun 22, 2026RuleMedical 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
drugdevicefood
Jun 22, 2026RuleMedical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Traction Device
drugdevicefood
Jun 18, 2026NoticeSpecGx LLC; Withdrawal of Approval of Abbreviated New Drug Application for Methylphenidate Hydrochloride Extended-Release Tablets, 27 Milligrams, 36 Milligrams, and 54 Milligrams
drugfood
Jun 18, 2026NoticeAdvisory Committee; Science Board to the Food and Drug Administration; Renewal
drugfood
Jun 18, 2026NoticeAgency 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
drugfood
Jul 20, 2026
Jun 18, 2026NoticeAgency 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
drugfood
Jul 20, 2026
Jun 18, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals
drugdevicefood
Aug 17, 2026
Jun 18, 2026NoticeAuthorization of Emergency Use for Two Animal Drugs for the Prevention and Treatment of New World Screwworm; Availability
drugfoodcosmetics
Jun 17, 2026RuleMedical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan
drugdevicefood
Jun 17, 2026NoticeAndrew Jonathan Morgan: Final Debarment Order
drugfoodcosmetics
Jun 17, 2026RuleMedical Devices; Gastroenterology-Urology Devices; Classification of the Ingestible Gastrointestinal Blood Detection Capsule
drugbiologicsdevice
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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.