[ 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)
99
Rules
24
Proposed rules
33
Open for comment
latest published 2026-07-30 · source: U.S. Federal Register (FDA)
⏳ CLOSING SOONEST · OPEN FOR PUBLIC COMMENT
COMMENTS CLOSE Jul 31, 2026
Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability
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 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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability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
681 matching documents
PublishedTypeTitleIndustryComments close
Nov 24, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization →
drugfood
Dec 24, 2025
Nov 24, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act →
drugdevicefood
Jan 23, 2026
Nov 24, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 510(k) Third-Party Review Program →
drugdevicefood
Dec 24, 2025
Nov 24, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emergency Use Authorization of Medical Products →
drugfood
Dec 24, 2025
Nov 24, 2025NoticeTobacco Products Scientific Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments →
drugfood
—
Nov 24, 2025NoticeIntercept Pharmaceuticals, Inc., et al.; Withdrawal of Approval of New Drug Application for OCALIVA (Obeticholic Acid) Tablets, 5 Milligrams and 10 Milligrams, and Three Abbreviated New Drug Applications for Obeticholic Acid Tablets, 5 Milligrams and 10 Milligrams →
drugfoodcosmetics
—
Nov 24, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ALTIUS DIRECT ELECTRICAL NERVE STIMULATION SYSTEM →
drugdevicefood
Jan 23, 2026
Nov 24, 2025NoticeImproving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine; Public Workshop; Request for Comments →
drugdevicefood
Jan 16, 2026
Nov 24, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ENVISION MAMMOGRAPHY PLATFORM →
drugdevicefood
Jan 23, 2026
Nov 24, 2025NoticeReauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments →
drugbiologicsfood
Jan 2, 2026
Nov 21, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Small Dispensers Assessment Under the Drug Supply Chain Security Act →
drugfood
Dec 22, 2025
Nov 21, 2025NoticeProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability →
drugdevicefood
Jan 20, 2026
Nov 21, 2025NoticeGeneral Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice-Establishment of Public Docket; Request for Comments →
drugdevicefood
—
Nov 20, 2025NoticeScientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies; Draft Guidance for Industry; Availability →
drugdevicefood
Jan 20, 2026
Nov 18, 2025NoticePatient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability →
drugfood
—
Nov 17, 2025NoticeMenstrual Products-Performance Testing and Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability →
drugdevicefood
Jan 16, 2026
Nov 17, 2025NoticeQuality Management System Information for Certain Premarket Submission Reviews; Draft Guidance for Industry and Food and Drug Administration Staff; Availability →
drugdevicefood
Jan 16, 2026
Nov 17, 2025NoticeConsiderations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use; Guidance for Industry; Availability →
drugdevicefood
—
Nov 17, 2025NoticeExpanded Access to Investigational Drugs for Treatment Use: Questions and Answers; Guidance for Industry; Availability →
drugbiologicsdevice
—
Nov 4, 2025NoticeCirculatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-V-Wave Ventura Interatrial Shunt System →
drugdevicefood
—
Oct 16, 2025NoticeDual Labeling for Fully Approved and Conditionally Approved New Animal Drugs With a New World Screwworm-Related Indication; Guidance for Industry; Availability →
drugfoodcosmetics
—
Oct 3, 2025NoticeTeva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 39 New Drug Applications; Correction →
drugfood
—
Oct 2, 2025NoticeRevocation of Emergency Use of Three Biological Products; Availability →
drugbiologicsfood
—
Oct 2, 2025NoticePediatric Advisory Committee (PAC); Notice of Meeting; Establishment of a Public Docket; Request for Comments →
drugfood
—
Oct 2, 2025NoticeProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability →
drugdevicefood
Dec 1, 2025
Page 20 of 28
← 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.