[ 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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability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 11, 2026NoticeButylated Hydroxyanisole (BHA); Request for Information
drugfood
Apr 13, 2026
Feb 11, 2026NoticeVoluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program
drugfood
Feb 6, 2026RuleNew Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address
drugfoodveterinary
Feb 6, 2026NoticeE22 General Considerations for Patient Preference Studies; International Council for Harmonisation; Draft Guidance for Industry; Availability
drugdevicefood
Apr 7, 2026
Feb 6, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; BEQVEZ
drugbiologicsfood
Apr 7, 2026
Feb 6, 2026RuleListing of Color Additives Exempt From Certification; Spirulina Extract
drugfoodcosmetics
Mar 9, 2026
Feb 6, 2026RuleListing of Color Additives Exempt From Certification; Beetroot Red
drugfoodcosmetics
Feb 6, 2026NoticePaul Zachary Lamberty: Final Debarment Order
drugfoodcosmetics
Feb 6, 2026NoticeMatthew Teltser: Final Debarment Order
drugdevicefood
Feb 6, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ALFAPUMP
drugdevicefood
Feb 6, 2026NoticeMedical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments
drugdevicefood
Apr 7, 2026
Feb 6, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; COBENFY
drugfood
Apr 7, 2026
Feb 6, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; AURORA EV-ICD
drugdevicefood
Feb 6, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Expedited Programs for Serious Conditions-Accelerated Approval of Drugs and Biologics
drugbiologicsdevice
Apr 7, 2026
Jan 30, 2026NoticeFDA Rare Disease Innovation Hub Future Programming; Request for Comments
drugfood
Dec 31, 2026
Jan 27, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; TRYVIO
drugfood
Mar 30, 2026
Jan 27, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; RYZNEUTA
drugbiologicsfood
Mar 30, 2026
Jan 27, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; EXBLIFEP
drugfood
Mar 30, 2026
Jan 27, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; BIMZELX
drugbiologicsfood
Mar 30, 2026
Jan 27, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Medication Guides for Prescription Drug Products
drugdevicefood
Mar 30, 2026
Jan 27, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; IMAAVY
drugbiologicsfood
Mar 30, 2026
Jan 27, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; Symplicity Spyral Renal Denervation System
drugdevicefood
Jan 27, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; REZDIFFRA
drugfood
Mar 30, 2026
Jan 23, 2026NoticeCuffless Non-Invasive Blood Pressure Measuring Devices-Clinical Performance Testing and Evaluation; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
drugbiologicsdevice
Mar 24, 2026
Jan 23, 2026NoticeTyler Jordan Hall: Final Debarment Order
drugfoodcosmetics
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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.