[ 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
26
Proposed rules
32
Open for comment
latest published 2026-07-29 · source: U.S. Federal Register (FDA)
⏳ CLOSING SOONEST · OPEN FOR PUBLIC COMMENT
COMMENTS CLOSE Jul 29, 2026
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Minor Use and Minor Species
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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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
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669 matching documents
PublishedTypeTitleIndustryComments close
Jul 22, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notifications Submission
drugdevicefood
Aug 21, 2026
Jul 21, 2026NoticeExpedited Investigational New Drug Pilot Program; Request for Information; Extension of the Comment Period
drugfood
Aug 24, 2026
Jul 20, 2026RuleFood Standards of Identity Modernization; Pasteurized Orange Juice
drugfood
Jul 17, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Cosmetic Products
drugdevicefood
Sep 15, 2026
Jul 17, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Voluntary National Retail Food Regulatory Program Standards
drugdevicefood
Sep 15, 2026
Jul 17, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Accreditation Scheme for Conformity Assessment Program
drugdevicefood
Sep 15, 2026
Jul 17, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Voluntary Improvement Program
drugdevicefood
Sep 15, 2026
Jul 17, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements
drugdevicefood
Sep 15, 2026
Jul 17, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Devices: (Medical Product Safety Network (MedSun))
drugdevicefood
Sep 15, 2026
Jul 16, 2026NoticeProcess for FDA Data Requests To Inform Certain Over-the-Counter Monograph Drug Activities; Procedure
drugdevicefood
Jul 14, 2026NoticeTopical Dermatologic Corticosteroids: In Vivo Bioequivalence; Guidance for Industry; Availability
drugdevicefood
Jul 14, 2026NoticeFormal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs
drugfoodcosmetics
Jul 14, 2026NoticePsychedelic Drugs: Considerations for Clinical Investigations; Guidance for Industry; Availability
drugfood
Jul 14, 2026NoticeConsiderations for Potential Future Therapeutic Use of Psychedelic Drugs; Public Hearing; Request for Comments
drugfood
Jul 13, 2026Proposed RuleDrug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
drugfood
Sep 11, 2026
Jul 9, 2026NoticeDetermination That TOVALT ODT (Zolpidem Tartrate) Orally Disintegrating Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
drugfood
Jul 8, 2026NoticeMedical Device User Fee Amendments; Public Meeting; Request for Comments
drugdevicefood
Jul 8, 2026NoticeCellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologics License Application (BLA) 125827, From Replimune, Inc. for Vusolimogene Oderparepvec
drugbiologicsfood
Jul 7, 2026RuleNew Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor
drugfoodveterinary
Jul 6, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Approval of Medical Devices
drugdevicefood
Aug 5, 2026
Jul 6, 2026NoticeDetermination That VASOPRESSIN IN SODIUM CHLORIDE (vasopressin) 0.9%, Injection, 50 units/50 milliliters (1 unit/milliliters) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
drugfood
Jul 6, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Practices and Procedures; Formal Hearings
drugfood
Aug 5, 2026
Jul 6, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Biologics License Applications, Procedures and Requirements
drugbiologicsdevice
Sep 4, 2026
Jul 6, 2026NoticeEndo Operations Limited, et al.; Withdrawal of Approval of 34 New Drug Applications
drugfood
Jul 6, 2026NoticeExpedited Investigational New Drug Pilot Program; Request for Information; Correction
drugfood
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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.