[ 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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability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 21, 2025RuleMedical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Menopause Test System
drugdevicefood
Aug 21, 2025RuleMedical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Pharmacogenetic Assessment System
drugdevicefood
Aug 21, 2025RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Mutation Detection Test for Myeloproliferative Neoplasms
drugdevicefood
Aug 21, 2025RuleMedical Devices; Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use With Total Disc Replacement Devices
drugdevicefood
Aug 21, 2025RuleListing of Color Additives Exempt From Certification; Calcium Phosphate; Confirmation of Effective Date
drugfood
Aug 21, 2025RuleListing of Color Additives Exempt From Certification; Galdieria Extract Blue; Confirmation of Effective Date
drugdevicefood
Aug 21, 2025RuleMedical Devices; Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use With Non-Fusion Spinous Process Spacer Devices
drugdevicefood
Aug 21, 2025RuleMedical Devices; Radiology Devices; Classification of the Liver Iron Concentration Imaging Companion Diagnostic for Deferasirox
drugdevicefood
Aug 21, 2025RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Postnatal Chromosomal Copy Number Variation Detection System
drugdevicefood
Aug 21, 2025RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Anti-Phospholipase A2 Receptor Immunological Test System
drugdevicefood
Aug 21, 2025RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Device That Detects Nucleic Acid Sequences From Microorganisms Associated With Vaginitis and Bacterial Vaginosis
drugdevicefood
Aug 19, 2025Proposed RuleEvonik Corporation; Filing of Food Additive Petition (Animal Use)
drugfoodveterinary
Aug 19, 2025NoticeApproaches to Assessment of Overall Survival in Oncology Clinical Trials; Draft Guidance for Industry; Availability
drugbiologicsfood
Oct 20, 2025
Aug 19, 2025NoticeLessons Learned From the Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Public Workshop; Request for Comments
drugfood
Oct 15, 2025
Aug 19, 2025NoticeDoyal Kalita: Final Debarment Order
drugfoodcosmetics
Aug 19, 2025NoticeOncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development; Draft Guidance for Industry; Availability
drugfood
Oct 20, 2025
Aug 19, 2025NoticeDetermination That RIFADIN (Rifampin) Capsules, 150 Milligrams and 300 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
drugdevicefood
Aug 15, 2025NoticeAdvancing the Development of Interchangeable Products: Identifying Future Needs; Public Workshop; Request for Comments
drugfood
Oct 19, 2025
Aug 15, 2025NoticeBiosimilar User Fee Act III Regulatory Science Program Interim Public Meeting; Public Meeting; Interim Report; Availability; Request for Comments
drugfood
Oct 18, 2025
Aug 15, 2025NoticeRevocation of Authorization of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
drugdevicefood
Aug 14, 2025Proposed RuleFood Standards of Identity Modernization; Pasteurized Orange Juice; Proposed Rule; Correction
drugfood
Aug 8, 2025NoticeProduct-Specific Guidance on Iron Sucrose; Draft Guidance for Industry; Availability
drugdevicefood
Oct 7, 2025
Aug 8, 2025NoticeOnshoring Manufacturing of Drugs and Biological Products; Public Meeting; Request for Comments
drugbiologicsdevice
Oct 30, 2025
Aug 7, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Collection of Conflict-of-Interest Information for Participation in Food and Drug Administration Non-Employee Fellowship and Traineeship Programs
drugdevicefood
Oct 6, 2025
Aug 7, 2025Proposed RuleRequirements for Additional Traceability Records for Certain Foods: Compliance Date Extension
drugfood
Sep 8, 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.