[ 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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability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
Dec 10, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; FILSUVEZ
drugfood
Feb 9, 2026
Dec 10, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; GRAFAPEX
drugfood
Feb 9, 2026
Dec 10, 2025NoticePromotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Availability
drugbiologicsfood
Dec 9, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Mammography Standards Quality Act Requirements
drugdevicefood
Feb 9, 2026
Dec 9, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Establishment, Maintenance, and Availability of Records; Additional Traceability Records for Certain Foods
drugdevicefood
Feb 9, 2026
Dec 9, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Humanitarian Use Devices
drugdevicefood
Jan 8, 2026
Dec 8, 2025NoticeRevocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability
drugdevicefood
Dec 8, 2025NoticeProduct-Specific Guidance on Estradiol; Draft Guidance for Industry; Availability
drugdevicefood
Feb 6, 2026
Dec 8, 2025NoticeTechnology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot
drugdevicefood
Dec 5, 2025NoticeProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
drugdevicefood
Feb 3, 2026
Dec 4, 2025RuleMedical Devices; Quality Management System Regulation Technical Amendments
drugdevicefood
Dec 3, 2025NoticeMonoclonal Antibodies: Streamlined Nonclinical Safety Studies; Draft Guidance for Industry; Availability
drugdevicefood
Feb 2, 2026
Dec 3, 2025NoticeQTc Information in Human Prescription Drug and Biological Product Labeling; Guidance for Industry; Availability
drugbiologicsfood
Dec 2, 2025NoticeIncreasing Access to Nonprescription Drugs; Request for Information
drugfood
Feb 2, 2026
Dec 1, 2025NoticeQ3E Guideline for Extractables and Leachables; International Council for Harmonisation; Draft Guidance for Industry; Availability
drugfood
Jan 30, 2026
Dec 1, 2025NoticeMedical Gases-Current Good Manufacturing Practice; Draft Guidance for Industry; Availability
drugfood
Jan 30, 2026
Dec 1, 2025NoticeFDA's Strategy Document on Innovative Manufacturing Technologies
drugfood
Nov 28, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Center for Devices and Radiological Health Appeals Processes
drugdevicefood
Dec 29, 2025
Nov 28, 2025Proposed RuleTesting Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products; Withdrawal
drugfoodcosmetics
Nov 26, 2025Proposed RuleGreen Innovation GmbH; Filing of Food Additive Petition (Animal Use)
drugfood
Nov 26, 2025RuleMedical Devices; Neurological Devices; Classification of Field Generator Positioning Device
drugdevicefood
Nov 26, 2025NoticeCross-Center Master Files: Where To Submit; Draft Guidance for Industry; Availability
drugbiologicsdevice
Feb 24, 2026
Nov 26, 2025RuleMedical Devices; Gastroenterology-Urology Devices; Classification of the Anchored Esophageal Sheath
drugdevicefood
Nov 25, 2025NoticeNicole Shelby Randall: Final Debarment Order
drugfoodcosmetics
Nov 25, 2025Proposed RuleImmunology and Microbiology Devices; Reclassification of Nucleic Acid-Based Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product; Proposed Amendment; Proposed Order; Request for Comments
drugdevicefood
Jan 26, 2026
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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.