[ 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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability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
Aug 26, 2025NoticeDetermination That Four Heparin Sodium In Sodium Chloride In Plastic Container (Heparin Sodium) Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
drugfood
Aug 26, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; SOFDRA
drugfood
Oct 27, 2025
Aug 26, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; CAMZYOS
drugbiologicsfood
Aug 26, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; OHTUVAYRE
drugfood
Oct 27, 2025
Aug 26, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; VORANIGO
drugfood
Oct 27, 2025
Aug 26, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ZUNVEYL
drugfood
Oct 27, 2025
Aug 26, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; YORVIPATH
drugfood
Oct 27, 2025
Aug 26, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Generally Recognized as Safe (GRAS): Notifications and Convening Panels
drugfood
Sep 25, 2025
Aug 26, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; NEMLUVIO
drugbiologicsfood
Oct 27, 2025
Aug 26, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; LUMISIGHT
drugfood
Oct 27, 2025
Aug 26, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; IQIRVO
drugfood
Oct 27, 2025
Aug 25, 2025NoticePrescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment; Public Meeting; Request for Comments
drugfood
Oct 24, 2025
Aug 22, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Retailer Training Programs
drugdevicefood
Oct 21, 2025
Aug 22, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents
drugdevicefood
Oct 21, 2025
Aug 22, 2025NoticeAnimal Studies for Dental Bone Grafting Material Devices-Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
drugdevicefood
Aug 22, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Reagents for Detection of Specific Novel Influenza A Viruses
drugfood
Sep 22, 2025
Aug 22, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishing and Maintaining Lists of United States Establishments With Interest in Exporting Human Food Program-Regulated Products
drugfood
Sep 22, 2025
Aug 22, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Animal Food and Egg Regulatory Program Standards
drugdevicefood
Oct 21, 2025
Aug 22, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records
drugdevicefood
Oct 21, 2025
Aug 22, 2025RuleNew Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
drugfoodveterinary
Aug 21, 2025RuleListing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract; Confirmation of Effective Date
drugfood
Aug 21, 2025RuleMedical Devices; Gastroenterology-Urology Devices; Classification of the Laparoscopic Gastrointestinal Sizing Tool
drugdevicefood
Aug 21, 2025NoticeFinancial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; Public Meeting; Request for Comments
drugfood
Oct 30, 2025
Aug 21, 2025RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Cancer Predisposition Risk Assessment System
drugdevicefood
Aug 21, 2025RuleMedical Devices; Immunology and Microbiology Devices; Classification of A Multiplex Respiratory Panel To Detect and Identify Emerging Respiratory Pathogen(s) and Common Respiratory Pathogens in Human Clinical Specimens
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.