[ 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)
99
Rules
24
Proposed rules
31
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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability
Reset
669 matching documents
PublishedTypeTitleIndustryComments close
May 7, 2026NoticeAdvisory Committee; Blood Products Advisory Committee; Renewal →
drugbiologicsfood
—
May 7, 2026NoticePatient-Matched Guides for Orthopedic Implants; Guidance for Industry and Food and Drug Administration Staff; Availability →
drugdevicefood
—
May 7, 2026NoticeDetermination That MICARDIS (Telmisartan), Tablets, 20 Milligrams and 80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness →
drugfood
—
May 7, 2026NoticeTeva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications →
drugfood
—
May 6, 2026RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Circulating Tumor Cell Enrichment Device →
drugdevicefood
—
May 6, 2026NoticeIssuance of Priority Review Voucher; Rare Pediatric Disease Product; OTARMENI (lunsotogene parvec-cwha) →
drugfoodcosmetics
—
May 6, 2026RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Device To Preserve and Stabilize Relative Abundances of Microbial Nucleic Acids in Clinical Samples →
drugdevicefood
—
May 6, 2026RuleMedical Devices; Ophthalmic Devices; Classification of the Corneal Storage Medium With Preservatives Including Antifungals →
drugdevicefood
—
May 6, 2026Proposed RuleModification of Certain Terminology in Title 21 →
drugbiologicsfood
Jul 6, 2026
May 6, 2026NoticeDetermination That DEXAMETHASONE (Dexamethasone) Elixir, 0.5 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness →
drugfood
—
May 4, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; National Youth Tobacco Survey →
drugdevicefood
Jul 6, 2026
May 1, 2026RuleMedical Devices; General and Plastic Surgery Devices; Classification of the Phototherapy Device for Reducing the Appearance of Acute Post-Surgical Incisions →
drugdevicefood
—
May 1, 2026NoticeObesity and Drug Dosing: Clinical Pharmacology Considerations; Request for Comments →
drugbiologicsdevice
Jun 30, 2026
May 1, 2026NoticeImpacts of Patient-Focused Drug Development Meetings; Establishment of a Public Docket; Request for Information and Comments →
drugfood
Jun 30, 2026
May 1, 2026NoticeList of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act →
drugfoodcosmetics
Jun 30, 2026
May 1, 2026NoticeMedical Devices; Exemptions From Premarket Notification: Certain Class II Devices; Request for Comments →
drugdevicefood
Jun 30, 2026
Apr 30, 2026RuleMedical Devices; Radiology Devices; Classification of the Radiation Therapy Marking Device →
drugdevicefood
—
Apr 30, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Requirements for Nonclinical Laboratory Studies →
drugdevicefood
Jun 29, 2026
Apr 30, 2026NoticeDetermination FENOGLIDE (Fenofibrate) Tablets, 40 Milligrams and 120 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness →
drugfood
—
Apr 30, 2026NoticeAdvisory Committee; Pharmacy Compounding Advisory Committee; Renewal →
drugfood
—
Apr 30, 2026NoticeDetermination That OZEMPIC (Semaglutide) Solution, 2 Milligrams Per 1.5 Milliliters Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness →
drugfood
—
Apr 30, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice →
drugfood
Jun 1, 2026
Apr 30, 2026RuleMedical Devices; Neurological Devices; Classification of the Brain Temperature Measurement System →
drugdevicefood
—
Apr 30, 2026RuleMedical Devices; Cardiovascular Devices; Classification of the Laser-Powered Inferior Vena Cava Filter Retrieval Catheter →
drugdevicefood
—
Apr 30, 2026NoticeChemoCentryx, Inc.; Proposal To Withdraw Approval of New Drug Application for TAVNEOS (Avacopan) Capsule, 10 Milligrams; Opportunity for a Hearing →
drugfood
Jun 29, 2026
Page 8 of 27
← PrevNext →

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.