[ 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)

Rules

Proposed rules

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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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

669 matching documents

Published	Type	Title	Industry	Comments close
Jul 29, 2026	Notice	Product-Specific Guidances; Revised Draft Guidances for Industry; Availability →	drugdevicefood	Sep 28, 2026
Jul 29, 2026	Notice	Statement of Organization, Functions, and Delegations of Authority →	drugfood	—
Jul 29, 2026	Rule	Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy →	drugdevicefood	—
Jul 28, 2026	Notice	Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability →	drugbiologicsfood	—
Jul 28, 2026	Notice	Fee Rate for Using a Priority Review Voucher in Fiscal Year 2026; Correction →	drugbiologicsdevice	—
Jul 28, 2026	Notice	Cancer Clinical Trial Eligibility Criteria: Performance Status; Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability →	drugbiologicsfood	—
Jul 28, 2026	Notice	Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability →	drugbiologicsfood	—
Jul 28, 2026	Notice	Pediatric Advisory Committee (PAC); Notice of Meeting; Establishment of a Public Docket; Request for Comments →	drugfood	—
Jul 28, 2026	Notice	Agency Information Collection Activities; Proposed Collection; Comment Request; Expanded Access to Investigational Drugs for Treatment Use →	drugdevicefood	Sep 28, 2026
Jul 27, 2026	Notice	Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees →	drugfood	Aug 26, 2026
Jul 27, 2026	Rule	Medical Devices; Gastroenterology-Urology Devices; Classification of the Non-Medicated Topical Formulation for Treatment of Erectile Dysfunction →	drugdevicefood	—
Jul 27, 2026	Rule	Medical Devices; General Hospital and Personal Use Devices; Classification of the Active Noise Attenuation System for Infant Incubators →	drugdevicefood	—
Jul 24, 2026	Proposed Rule	Evonik Corporation, Filing of Food Additive Petition (Animal Use) →	drugfood	—
Jul 24, 2026	Notice	Francis Esteban Matos: Final Debarment Order →	drugfoodcosmetics	—
Jul 24, 2026	Rule	Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Chronic Kidney Disease Progression →	drugdevicefood	—
Jul 24, 2026	Rule	Medical Devices; General Hospital and Personal Use Devices; Classification of the Diabetes Digital Behavioral Therapeutic Device →	drugdevicefood	—
Jul 24, 2026	Rule	Medical Devices; Immunology and Microbiology Devices; Classification of the Over-the-Counter Test To Detect SARS-CoV-2 From Clinical Specimens →	drugdevicefood	—
Jul 24, 2026	Rule	Medical Devices; Orthopedic Devices; Classification of the Intraoperative Surgical Angle Measurement Tool →	drugdevicefood	—
Jul 24, 2026	Notice	Cellular, Tissue, and Gene Therapies Advisory Committee; Amendment of Notice-Biologics License Application (BLA) 125842 From Capricor, Inc. for Deramiocel (Human Allogeneic Cardiosphere-Derived Cells) →	drugbiologicsfood	—
Jul 24, 2026	Notice	Cellular, 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 23, 2026	Notice	Advisory Committee; Peripheral and Central Nervous System Drugs Advisory Committee; Termination and Reestablishment →	drugfood	—
Jul 23, 2026	Rule	Revocation of the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausages →	drugfood	—
Jul 23, 2026	Notice	FDA's Strategy Document on Facilitating Chemistry, Manufacturing, and Controls Readiness for Products With Accelerated Clinical Development →	drugbiologicsfood	—
Jul 23, 2026	Proposed Rule	Proposal To Revoke the Color Additive Listing for Use of Citrus Red No. 2 on the Skins of Mature Oranges →	drugfood	Aug 24, 2026
Jul 22, 2026	Notice	Determination That RASUVO (Methotrexate) Solution, 27.5 Milligrams/0.55 Milliliter (27.5 Milligrams/0.55 Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness →	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.