[ 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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability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Sep 25, 2025NoticeInnovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations; Draft Guidance for Industry; Availability →
drugbiologicsfood
Nov 24, 2025
Sep 24, 2025NoticeComputer Software Assurance for Production and Quality System Software; Guidance for Industry and Food and Drug Administration Staff; Availability →
drugdevicefood
—
Sep 24, 2025NoticeApproval of Previously Withdrawn New Drug Application for WELLCOVORIN (Leucovorin Calcium) Tablets →
drugfood
—
Sep 24, 2025NoticeADUFA V Third-Party Assessment Report: Notice of Availability; Virtual Public Meeting; Request for Comments →
drugfoodveterinary
Dec 30, 2025
Sep 24, 2025NoticeElite Laboratories, Inc., et al.; Withdrawal of Approval of 72 Abbreviated New Drug Applications →
drugfood
—
Sep 23, 2025NoticeMalaria: Developing Drugs for Treatment; Draft Guidance for Industry; Availability →
drugbiologicsfood
Dec 22, 2025
Sep 23, 2025NoticeConsideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency; Guidance for Industry and Food and Drug Administration Staff; Availability →
drugdevicefood
—
Sep 22, 2025NoticeAdvancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development-Leveraging Rare Disease Frameworks; Public Meeting →
drugfood
—
Sep 19, 2025NoticeSafety Labeling Changes-Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability →
drugbiologicsfood
Nov 18, 2025
Sep 19, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request, Exemptions From Substantial Equivalence Requirements for Tobacco Products →
drugfood
Oct 20, 2025
Sep 19, 2025NoticeWilliam Goldsmith: Final Debarment Order →
drugfoodcosmetics
—
Sep 19, 2025NoticeVaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Southern Hemisphere Influenza Virus Vaccines; Center for Biologics Evaluation and Research (CBER) Allergen Standardization Program →
drugbiologicsfood
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Sep 19, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Health Document Submission →
drugfood
Oct 20, 2025
Sep 19, 2025RuleRegulation Identification Number 0910-AJ05 Medical Devices; Laboratory Developed Tests; Implementation of Vacatur →
drugdevicefood
—
Sep 19, 2025RuleNew Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address; Correction →
drugfoodveterinary
—
Sep 19, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Considerations →
drugfood
Oct 20, 2025
Sep 19, 2025NoticeUltra-Processed Foods; Request for Information; Extension of Comment Period →
—
Jul 25, 2025
Sep 19, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Meetings With Industry and Investigators on the Research and Development of Tobacco Products →
drugfood
Oct 20, 2025
Sep 18, 2025NoticeFee Rate for Using a Priority Review Voucher in Fiscal Year 2026 →
drugbiologicsfood
—
Sep 18, 2025RuleRadiological Health Regulations; Technical Amendments →
drugdevicefood
—
Sep 18, 2025RuleMicrobiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices →
drugdevicefood
—
Sep 17, 2025NoticeSymptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability →
drugdevicefood
Nov 17, 2025
Sep 17, 2025NoticeDisseminated Coccidioidomycosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability →
drugfood
Nov 17, 2025
Sep 17, 2025Proposed RuleProposal To Remove the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausages →
drugfood
Oct 17, 2025
Sep 17, 2025NoticeErosive Esophagitis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability →
drugdevicefood
Nov 17, 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.