[ 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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability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 19, 2026NoticeJustin Insprucker: Final Debarment Order →
drugfoodcosmetics
—
Feb 19, 2026NoticeSherri Insprucker: Final Debarment Order →
drugfoodcosmetics
—
Feb 19, 2026RuleRevocation of Methods of Analysis Regulation →
drugfood
—
Feb 19, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; SYMVESS →
drugbiologicsfood
Apr 20, 2026
Feb 18, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents →
drugfood
Mar 20, 2026
Feb 18, 2026NoticeDetermination That TOLECTIN DS (Tolmetin Sodium) Capsule, Equivalent to 400 Milligrams Base, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness →
drugfood
—
Feb 18, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request Data To Support Social and Behavioral Research as Used by the Food and Drug Administration →
drugfood
Mar 20, 2026
Feb 18, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emerging Drug Safety Technology Program →
drugfood
Mar 20, 2026
Feb 18, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Patent Term Restoration; Due Diligence Petitions; Filing, Format, and Content of Petitions →
drugdevicefood
Apr 20, 2026
Feb 18, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Quick Turnaround Testing of Communication Effectiveness →
drugfood
Mar 20, 2026
Feb 18, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Q-Submission and Early Payor Feedback Request Programs and Medical Device Development Tools →
drugdevicefood
Mar 20, 2026
Feb 18, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Products Requirements →
drugfood
Mar 20, 2026
Feb 18, 2026NoticeIssuance of Priority Review Voucher; Rare Pediatric Disease Product; ZEVASKYN (Prademagene Zamikeracel) →
drugfoodcosmetics
—
Feb 13, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; RYTELO →
drugfood
Apr 14, 2026
Feb 13, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; BLUJEPA →
drugfood
Apr 14, 2026
Feb 13, 2026NoticeDefining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals; Guidance for Industry; Availability →
drugfoodveterinary
—
Feb 13, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ALYFTREK →
drugfood
Apr 14, 2026
Feb 13, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; AUCATZYL →
drugbiologicsfood
Apr 14, 2026
Feb 13, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; CRENESSITY →
drugfood
Apr 14, 2026
Feb 13, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; AMTAGVI →
drugbiologicsfood
Apr 14, 2026
Feb 13, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; KEBILIDI →
drugbiologicsfood
Apr 14, 2026
Feb 13, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ATTRUBY →
drugfood
Apr 14, 2026
Feb 12, 2026NoticeJeremy Spencer Brown: Final Debarment Order →
drugfoodcosmetics
—
Feb 12, 2026NoticeCertification Process for Designated Medical Gases; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request →
drugfood
Apr 13, 2026
Feb 12, 2026NoticeVaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-United States (U.S.) 2026-2027 Influenza Vaccine Strain Composition →
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.