[ 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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability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
Jul 1, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medication Guides for Prescription Drug Products →
drugfood
Jul 31, 2026
Jun 30, 2026RuleMedical Devices; Anesthesiology Devices; Classification of the Monitor for Opioid Induced Impairment of Oxygenation →
drugdevicefood
—
Jun 30, 2026RuleMedical Devices; General and Plastic Surgery Devices; Classification of the Skin Patch for Treatment of Hyperhidrosis →
drugdevicefood
—
Jun 29, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Minor Use and Minor Species →
drugfoodveterinary
Jul 29, 2026
Jun 29, 2026Proposed RuleEstablishment Registration and Product Listing for Tobacco Products →
drugfood
Sep 14, 2026
Jun 29, 2026NoticeCellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologics License Application (BLA) 125842 From Capricor, Inc. for Deramiocel (Human Allogeneic Cardiosphere-Derived Cells) →
drugbiologicsfood
—
Jun 29, 2026RuleMedical Devices; Orthopedic Devices; Classification of the Medial Knee Implanted Shock Absorber →
drugdevicefood
—
Jun 29, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; VYALEV →
drugfood
Dec 28, 2026
Jun 26, 2026RuleMedical Devices; General Hospital and Personal Use Devices; Classification of the Infant Supine Sleep System →
drugdevicefood
—
Jun 26, 2026NoticeDetermination That Prednisolone Tablet, 5 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness →
drugfood
—
Jun 26, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Time and Extent Applications for Nonprescription Drug Products →
drugdevicefood
Aug 25, 2026
Jun 26, 2026RuleMedical Devices; General and Plastic Surgery Devices; Classification of the Breast Implant Suction Retrieval System →
drugdevicefood
—
Jun 26, 2026NoticeRevocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability →
drugdevicefood
—
Jun 26, 2026RuleMedical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for the Treatment of Fibromyalgia Symptoms →
drugdevicefood
—
Jun 26, 2026RuleMedical Devices; Clinical Chemistry and Toxicology Devices; Classification of the Prognostic Test for Development or Progression of Preeclampsia →
drugdevicefood
—
Jun 26, 2026RuleMedical Devices; General Hospital and Personal Use Devices; Classification of the Foam or Gel Chemical Sterilant/High Level Disinfectant →
drugdevicefood
—
Jun 26, 2026RuleMedical Devices; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test →
drugdevicefood
—
Jun 26, 2026RuleMedical Devices; Neurological Devices; Classification of the External Lower Extremity Nerve Stimulator for Restless Legs Syndrome →
drugdevicefood
—
Jun 26, 2026NoticeDrugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Extension of Effective Date of Final Resolution of Drug Efficacy Study Implementation 7661 →
drugfood
—
Jun 26, 2026NoticeList of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period →
drugfoodcosmetics
May 1, 2026
Jun 26, 2026NoticeDetermination That RECTIV (Nitroglycerin) Ointment, 0.4%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness →
drugfood
—
Jun 25, 2026Proposed RuleSterigenics U.S., LLC; Filing of Food Additive Petition →
drugfood
—
Jun 24, 2026NoticeMaster Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Availability →
drugbiologicsfood
Aug 24, 2026
Jun 24, 2026NoticeExpedited Investigational New Drug Pilot Program; Request for Information →
drugfood
Jul 22, 2026
Jun 24, 2026NoticeInternational Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Canines; Guidance for Industry; Availability →
drugfoodveterinary
—
Page 3 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.