[ 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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability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
Jan 22, 2026NoticeLabeling and Preventing Cross-Contact of Gluten for Packaged Foods; Request for Information
drugfood
Mar 23, 2026
Jan 22, 2026NoticeFDA Records Access Authority for Cosmetics; Draft Guidance for Industry; Availability
drugfoodcosmetics
Mar 23, 2026
Jan 21, 2026NoticeIssuance of Priority Review Voucher; Rare Pediatric Disease Product; KYGEVVI (Doxecitine and Doxribtimine)
drugfoodcosmetics
Jan 21, 2026NoticeNotice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; RHAPSIDO (Remibrutinib)
drugfoodcosmetics
Jan 21, 2026NoticeM4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality; International Council for Harmonisation; Draft Guidance for Industry; Availability
drugfood
Mar 23, 2026
Jan 21, 2026NoticeAuthorization of Emergency Use of Certain Medical Devices During COVID-19; Availability
drugdevicefood
Jan 21, 2026NoticeMinimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints To Support Accelerated Approval; Draft Guidance for Industry; Availability
drugbiologicsfood
Mar 23, 2026
Jan 16, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Warning Plans for Certain Tobacco Products
drugfood
Feb 17, 2026
Jan 12, 2026NoticeUse of Bayesian Methodology in Clinical Trials of Drug and Biological Products; Draft Guidance for Industry; Availability
drugbiologicsfood
Mar 13, 2026
Jan 6, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ZURZUVAE
drugfood
Mar 9, 2026
Jan 5, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; IZERVAY
drugfood
Mar 6, 2026
Jan 5, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; MEDIBEACON
drugdevicefood
Jan 5, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; AUGTYRO
drugfood
Mar 6, 2026
Jan 5, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; BRENZAVVY
drugfood
Mar 6, 2026
Jan 2, 2026NoticeRevocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
drugdevicefood
Jan 2, 2026NoticeDetermination That MYSOLINE (Primidone) Suspension, 250 Milligrams/5 Milliliters, Was Withdrawn From Sale for Reasons of Safety or Effectiveness
drugfood
Dec 29, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ADZYNMA
drugbiologicsfood
Feb 27, 2026
Dec 29, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; OJEMDA
drugfood
Feb 27, 2026
Dec 29, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ALHEMO
drugbiologicsfood
Feb 27, 2026
Dec 29, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ZELSUVMI
drugfood
Jun 29, 2026
Dec 29, 2025NoticeEgis Pharmaceuticals Limited, et.al.; Proposal To Withdraw Approval of Three Abbreviated New Drug Applications; Opportunity for a Hearing
drugfood
Feb 27, 2026
Dec 29, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ROMVIMZA
drugfood
Feb 27, 2026
Dec 29, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practices for Positron Emission Tomography Drugs
drugfood
Jan 28, 2026
Dec 29, 2025NoticeOver-the-Counter Monograph Drug User Fee Amendments-OTC Monograph Order Request Fee Rates for Fiscal Year 2026
drugfoodcosmetics
Dec 29, 2025NoticeMedical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices
drugdevicefood
Feb 27, 2026
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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.