[ 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.

636

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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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

COMMENTS CLOSE Aug 14, 2026

Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability

669 matching documents

Published	Type	Title	Industry	Comments close
Jun 1, 2026	Rule	Medical Devices; Anesthesiology Devices; Classification of the Real-Time Ultrasound Anatomy Visualization and Labeling Device for Ultrasound Guided Regional Anesthesia →	drugdevicefood	—
Jun 1, 2026	Rule	Medical Devices; General Hospital and Personal Use Devices; Classification of the Rigid Sterilization Container With Electronic Monitoring →	drugdevicefood	—
Jun 1, 2026	Rule	Medical Devices; Hematology and Pathology Devices; Classification of the Von Willebrand Factor Assay →	drugdevicefood	—
Jun 1, 2026	Rule	Medical Devices; Dental Devices; Classification of the Intraoral Cooling Device →	drugdevicefood	—
Jun 1, 2026	Notice	Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability →	drugbiologicsdevice	Jul 31, 2026
Jun 1, 2026	Rule	Medical Devices; Ear, Nose, and Throat Devices; Classification of the Oropharyngeal Electrical Stimulator →	drugdevicefood	—
May 29, 2026	Notice	Patient-Focused Drug Development for Nonhealing Chronic Wounds; Public Meeting; Request for Comments →	drugfood	Oct 26, 2026
May 29, 2026	Notice	Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Guidance for Industry; Availability →	drugdevicefood	—
May 29, 2026	Notice	Advisory Committee; Psychopharmacologic Drugs Advisory Committee; Renewal →	drugfood	—
May 29, 2026	Rule	Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms →	drugdevicefood	—
May 29, 2026	Notice	Statistical Approaches To Establishing Bioequivalence; Guidance for Industry; Availability →	drugdevicefood	—
May 29, 2026	Notice	Content of Human Factors Information in Medical Device Marketing Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability →	drugdevicefood	—
May 28, 2026	Notice	AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information; Extension of Comment Period →	drugfood	Jun 29, 2026
May 28, 2026	Proposed Rule	Color Additive Petition from Environmental Defense Fund, et al.; Request To Amend the Color Additive Regulations To Remove the Solvents Ethylene Dichloride, Methylene Chloride, and Trichloroethylene; Reopening of the Comment Period →	drugfood	Jun 29, 2026
May 28, 2026	Rule	Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Suturing Device for Altering Gastric Anatomy for Weight Loss →	drugdevicefood	—
May 28, 2026	Notice	Challenges and Solutions in Lot-Level Food Traceability; Public Meeting and Request for Comments →	drugfood	Jul 15, 2026
May 28, 2026	Proposed Rule	Food Additive Petition From Environmental Defense Fund, et al.; Request To Amend the Food Additive Regulations To Remove the Solvents Benzene, Ethylene Dichloride, Methylene Chloride, and Trichloroethylene; Reopening of the Comment Period →	drugfood	Jun 29, 2026
May 27, 2026	Notice	Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Syntest D.S. and Syntest H.S. Tablets; Withdrawal of Hearing Requests; Final Resolution of Drug Efficacy Study Implementation 7661 →	drugfood	—
May 26, 2026	Notice	Advisory Committee; Drug Safety and Risk Management Advisory Committee; Renewal →	drugfood	—
May 26, 2026	Notice	Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act →	drugdevicefood	Jul 27, 2026
May 26, 2026	Notice	Advisory Committee; Pulmonary-Allergy Drugs Advisory Committee; Renewal →	drugfood	—
May 22, 2026	Notice	Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Safety and Effectiveness of MFLUSIVA (Influenza Vaccine, mRNA) Manufactured by Moderna TX Inc. →	drugbiologicsfood	—
May 22, 2026	Notice	M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP); International Council for Harmonisation; Guidance for Industry; Availability →	drugdevicefood	—
May 22, 2026	Notice	Protein Efficiency Ratio Rat Bioassay Studies To Demonstrate That a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein; Guidance for Industry; Availability →	drugbiologicsdevice	—
May 22, 2026	Notice	Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability →	drugdevicefood	Jul 21, 2026

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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.