[ 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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability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
Jul 14, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Electronic Products
drugdevicefood
Sep 12, 2025
Jul 14, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; LAZCLUZE
drugfood
Sep 12, 2025
Jul 14, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; TECELRA
drugbiologicsfood
Sep 12, 2025
Jul 14, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Emergency Use Authorization of Medical Products
drugdevicefood
Sep 12, 2025
Jul 14, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; IMDELLTRA
drugbiologicsfood
Sep 12, 2025
Jul 14, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ABRYSVO
drugbiologicsfood
Sep 12, 2025
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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.