[ 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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability
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681 matching documents
PublishedTypeTitleIndustryComments close
Oct 2, 2025NoticeRevocation of Emergency Use of a Biological Product; Availability
drugbiologicsfood
Oct 1, 2025RuleListing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue; Confirmation of Effective Date
drugfood
Oct 1, 2025NoticeYong Sheng Jiao: Denial of Application for Termination of Debarment
drugfoodcosmetics
Oct 1, 2025NoticeJason Oppenheimer: Final Debarment Order
drugfoodcosmetics
Sep 30, 2025NoticeE20 Adaptive Designs for Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; Availability
drugfood
Dec 1, 2025
Sep 29, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United States
drugfood
Oct 29, 2025
Sep 29, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; TRICLIP
drugdevicefood
Sep 29, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; MIPLYFFA
drugfood
Nov 28, 2025
Sep 29, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; NIKTIMVO
drugbiologicsfood
Nov 28, 2025
Sep 29, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mitigation Strategies To Protect Food Against Intentional Adulteration
drugfood
Oct 29, 2025
Sep 29, 2025NoticeDetermination That SEMPREX-D (Acrivastine and Pseudoephedrine Hydrochloride) Capsules, 8 Milligrams and 60 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
drugfood
Sep 29, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and Issue Certifications
drugdevicefood
Oct 29, 2025
Sep 29, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE
drugdevicefood
Sep 26, 2025RuleRevocation of Food Standards for 11 Products Not Currently Sold; Confirmation of Effective Date
drugfood
Sep 25, 2025NoticeExpedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry; Availability
drugfood
Nov 24, 2025
Sep 25, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Agreement for Shipment of Devices for Sterilization
drugdevicefood
Oct 27, 2025
Sep 25, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act
drugfoodcosmetics
Oct 27, 2025
Sep 25, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Sanitary Transportation of Human and Animal Food
drugfoodveterinary
Oct 27, 2025
Sep 25, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Prohibited From Use in Animal Food or Feed
drugfoodveterinary
Oct 27, 2025
Sep 25, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Food Facilities
drugfood
Oct 27, 2025
Sep 25, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Production, Storage, and Transportation of Shell Eggs (Preventing Salmonella Enteritidis)
drugfood
Oct 27, 2025
Sep 25, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices for Positron Emission Tomography Drugs
drugdevicefood
Nov 24, 2025
Sep 25, 2025NoticeAgency Information Collection Activities; Announcement of Office of Management and Budget Approvals
drugfood
Sep 25, 2025NoticePostapproval Methods To Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Draft Guidance for Industry; Availability
drugbiologicsfood
Dec 24, 2025
Sep 25, 2025RulePrior Notice: Adding Requirement To Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe for Post-Refusal and Post-Hold Submissions
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.