[ 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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability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 16, 2026	Notice	Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, et al.; Withdrawal of Approval of 11 Abbreviated New Drug Applications; Correction →	drugfood	—
Jun 15, 2026	Notice	Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability →	drugfood	Aug 14, 2026
Jun 15, 2026	Rule	Amendment and Revocation of Organizational Information Regulations →	drugfood	—
Jun 11, 2026	Notice	Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Procedures for the Safe Processing and Importing of Fish and Fishery Products →	drugfood	Jul 13, 2026
Jun 11, 2026	Notice	Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments; Reopening of the Comment Period →	drugfood	Jul 13, 2026
Jun 11, 2026	Notice	Drug Repurposing for Unmet Medical Needs; Request for Information; Extension of Comment Period →	drugfood	Jul 13, 2026
Jun 11, 2026	Rule	Medical Devices; Immunology and Microbiology Devices; Classification of the Simple Point-of-Care Device to Directly Detect SARS-CoV-2 Viral Targets From Clinical Specimens in Near-Patient Settings →	drugdevicefood	—
Jun 11, 2026	Rule	Medical Devices; Immunology and Microbiology Devices; Classification of the Spinal Muscular Atrophy Newborn Screening Test System →	drugdevicefood	—
Jun 11, 2026	Notice	Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment, Maintenance, and Availability of Records; Additional Traceability Records for Certain Foods →	drugfood	Jul 13, 2026
Jun 10, 2026	Notice	Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information →	drugfood	—
Jun 10, 2026	Rule	Medical Devices; Ear, Nose, and Throat Devices; Classification of the Combined Acoustic and Electrical External Stimulation Device for the Relief of Tinnitus →	drugdevicefood	—
Jun 8, 2026	Notice	Determination That Protamine Sulfate (Protamine Sulfate) Intravenous; Solution, 50 Milligrams/5 Milliliters, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness →	drugfood	—
Jun 5, 2026	Rule	Medical Devices; Orthopedic Devices; Classification of the Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented or Uncemented Prosthesis →	drugdevicefood	—
Jun 5, 2026	Rule	Medical Devices; Orthopedic Devices; Classification of the Absorbable Metallic Bone Fixation Fastener →	drugdevicefood	—
Jun 5, 2026	Notice	Intent To Exempt Certain Unclassified Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability →	drugdevicefood	—
Jun 5, 2026	Rule	Medical Devices; Orthopedic Devices; Classification of the Resorbable Calcium Salt Bone Void Filler Containing a Single Approved Aminoglycoside Antibacterial →	drugdevicefood	—
Jun 3, 2026	Notice	Vanda Pharmaceuticals, Inc.; Grant of Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon) →	drugfood	—
Jun 3, 2026	Notice	Third Annual Animal Drug User Fee Educational Conference; Public Meeting →	drugfoodveterinary	—
Jun 3, 2026	Notice	Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry; Availability →	drugbiologicsfood	Sep 1, 2026
Jun 3, 2026	Notice	Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications →	drugfood	—
Jun 3, 2026	Rule	New 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	—
Jun 3, 2026	Notice	M15 General Principles for Model-Informed Drug Development; International Council for Harmonisation; Guidance for Industry; Availability →	drugdevicefood	—
Jun 3, 2026	Notice	Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability →	drugdevicefood	Aug 3, 2026
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; Anesthesiology Devices; Classification of the Adjunctive Pain Measurement Device for Anesthesiology →	drugdevicefood	—

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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.