[ 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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability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
Jul 29, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export Notification and Recordkeeping Requirements
drugfood
Aug 28, 2025
Jul 29, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
drugfood
Aug 28, 2025
Jul 29, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tropical Disease Priority Review Vouchers
drugfood
Aug 28, 2025
Jul 29, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Reporting
drugdevicefood
Aug 28, 2025
Jul 29, 2025NoticeAgency Information Collection Activities; Announcement of Office of Management and Budget Approvals
drugfood
Jul 29, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Compounding Animal Drugs From Bulk Drug Substances
drugfoodveterinary
Aug 28, 2025
Jul 29, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation
drugfood
Aug 28, 2025
Jul 29, 2025NoticeRevocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability
drugdevicefood
Jul 29, 2025Proposed RuleAPIX Biosciences US LLC; Filing of Food Additive Petition (Animal Use)
drugfood
Jul 29, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products
drugfood
Aug 28, 2025
Jul 28, 2025RuleRegulatory Hearing Before the Food and Drug Administration
drugfood
Jul 25, 2025NoticeUltra-Processed Foods; Request for Information
food
Sep 23, 2025
Jul 21, 2025NoticeE21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; Availability
drugfood
Sep 19, 2025
Jul 21, 2025NoticeFormal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products; Guidance for Industry; Availability
drugbiologicsdevice
Jul 17, 2025Proposed RuleRevocation of Food Standards for 11 Products Not Currently Sold
drugfood
Aug 18, 2025
Jul 17, 2025Proposed RuleProposal To Revoke 18 Standards of Identity for Dairy Products
drugfood
Sep 15, 2025
Jul 17, 2025Proposed RuleProposal To Revoke 23 Standards of Identity for Foods
drugfood
Sep 15, 2025
Jul 17, 2025RuleRevocation of Food Standards for 11 Products Not Currently Sold
drugfood
Aug 18, 2025
Jul 17, 2025NoticeDevelopment of Cancer Drugs for Use in Novel Combination-Determining the Contribution of the Individual Drugs' Effects; Draft Guidance for Industry; Availability
drugfood
Sep 15, 2025
Jul 16, 2025NoticeRecommendations for Testing Blood Donations for Hepatitis B Surface Antigen; Draft Guidance for Industry; Availability
drugbiologicsdevice
Oct 14, 2025
Jul 15, 2025RuleListing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue
drugfood
Jul 14, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; KISUNLA
drugbiologicsfood
Sep 12, 2025
Jul 14, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; The Real Cost Campaign Outcomes Evaluation Study: Cohort 3
drugdevicefood
Sep 12, 2025
Jul 14, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; HEMGENIX
drugbiologicsfood
Sep 12, 2025
Jul 14, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Q-Submission and Early Payor Feedback Request Programs and Medical Device Development Tools
drugdevicefood
Sep 12, 2025
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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.