[ 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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability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
Sep 12, 2025NoticeAlternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications; Guidance for Industry; Availability
drugbiologicsfood
Sep 12, 2025NoticeDigital Health Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Generative Artificial Intelligence-Enabled Digital Mental Health Medical Devices
drugdevicefood
Sep 11, 2025NoticeDevelopment of Non-Opioid Analgesics for Chronic Pain, Draft Guidance for Industry; Availability
drugfood
Nov 10, 2025
Sep 9, 2025NoticeDevelopment of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations; Guidance for Industry; Availability
drugdevicefood
Sep 9, 2025NoticeE6(R3) Good Clinical Practice; International Council for Harmonisation; Guidance for Industry; Availability
drugfood
Sep 9, 2025NoticeM13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver; International Council for Harmonisation; Draft Guidance for Industry; Reopening of the Comment Period
drugfood
Oct 9, 2025
Sep 9, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Product Establishment Registration and Listing
drugfood
Oct 9, 2025
Sep 9, 2025NoticeClassification Categories for Certain Supplements Under Biosimilar User Fee Amendments III; Guidance for Industry; Availability
drugfood
Sep 5, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Manufactured Food Regulatory Program Standards
drugfood
Oct 6, 2025
Sep 4, 2025NoticeBausch & Lomb Incorporated, et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications; Correction
drugfood
Sep 4, 2025RuleFood Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 in Yogurt and Other Cultured Dairy Products Fermented With Lactobacillus delbrueckii, Subspecies bulgaricus, and Streptococcus thermophilus
drugfood
Sep 3, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Accessories
drugdevicefood
Oct 3, 2025
Sep 3, 2025NoticeDetermination That NUTRACORT (Hydrocortisone) Topical Gel, 1%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
drugfood
Sep 3, 2025NoticeGeneral Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
drugdevicefood
Sep 3, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices; Foreign Letters of Approval
drugdevicefood
Oct 3, 2025
Sep 3, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; FDA Food Safety and Nutrition Survey
drugfood
Oct 3, 2025
Sep 3, 2025RuleSecondary Direct Food Additives Permitted in Food for Human Consumption; Hydrogen Peroxide
drugfood
Oct 3, 2025
Sep 3, 2025Proposed RuleBiomin GmbH; Filing of Food Additive Petition (Animal Use)
drugfood
Aug 29, 2025RuleAdvisory Committee; Arthritis Advisory Committee; Termination; Removal From List of Standing Committees
drugfood
Aug 29, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Submissions of Medical Device Registration and Listing
drugdevicefood
Sep 29, 2025
Aug 29, 2025NoticeAmylyx Pharmaceuticals, Inc.; Withdrawal of Approval of New Drug Application for RELYVRIO (Sodium Phenylbutyrate and Taurursodiol) for Suspension, 3 Gram/Packet and 1 Gram/Packet
drugfood
Aug 28, 2025NoticePatient-Focused Drug Development: Workshop #2 To Discuss Methodologic and Other Challenges Related to Patient Experience Data; Public Workshop; Request for Comments
drugfood
Nov 18, 2025
Aug 28, 2025NoticeIssuance of Priority Review Voucher; Rare Pediatric Disease Product; MODESYO (dordaviprone)
drugfoodcosmetics
Aug 28, 2025NoticeChemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement
drugbiologicsfood
Aug 26, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; PIASKY
drugbiologicsfood
Oct 27, 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.