[ 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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability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 7, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products →
drugdevicefood
Oct 6, 2025
Aug 7, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Humanitarian Use Devices →
drugdevicefood
Oct 6, 2025
Aug 6, 2025RuleListing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue; Correction →
drugfood
—
Aug 6, 2025Proposed RuleFood Standards of Identity Modernization; Pasteurized Orange Juice →
drugfood
Nov 4, 2025
Aug 4, 2025NoticeTeva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction →
drugfood
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Aug 4, 2025NoticeTeva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 39 New Drug Applications →
drugfood
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Aug 4, 2025NoticePrescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application Review; Final Report; Availability; Reopening of Comment Period →
drugfood
Sep 3, 2025
Aug 4, 2025NoticeDetermination That HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (Heparin Sodium) Injectable, 200 Units/100 Milliliters, and Two Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness →
drugfood
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Aug 4, 2025NoticeDetermination That ROXICET (Oxycodone Hydrochloride and Acetaminophen) Tablet, 5 Milligrams and 325 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness →
drugfood
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Jul 31, 2025NoticeMedical Device User Fee Small Business Qualification and Determination Guidance Final Guidance for Industry and Food and Drug Administration Staff and Foreign Governments; Availability →
drugdevicefood
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Jul 30, 2025NoticeTobacco Products Scientific Advisory Committee; Notice of Meeting →
drugfood
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Jul 30, 2025NoticeBiosimilar User Fee Rates for Fiscal Year 2026 →
drugbiologicsfood
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Jul 30, 2025NoticeFood Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2026 →
drugfoodcosmetics
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Jul 30, 2025NoticePrescription Drug User Fee Rates for Fiscal Year 2026 →
drugbiologicsfood
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Jul 30, 2025NoticeGeneric Drug User Fee Rates for Fiscal Year 2026 →
drugfoodcosmetics
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Jul 30, 2025NoticeOutsourcing Facility Fee Rates for Fiscal Year 2026 →
drugfoodcosmetics
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Jul 30, 2025NoticeAnimal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2026 →
drugfoodcosmetics
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Jul 30, 2025NoticeFood Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2026 →
drugfoodcosmetics
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Jul 30, 2025NoticeFood Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2026 →
drugfoodcosmetics
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Jul 30, 2025NoticeGeneral and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice-Establishment of Public Docket; Request for Comments-Dermal Fillers →
drugdevicefood
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Jul 30, 2025NoticeArthritis Advisory Committee; Termination →
drugfood
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Jul 30, 2025NoticeAnimal Drug User Fee Rates and Payment Procedures for Fiscal Year 2026 →
drugfoodcosmetics
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Jul 30, 2025NoticeMedical Device User Fee Rates for Fiscal Year 2026 →
drugdevicefood
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Jul 29, 2025Proposed RuleSpoonbill Foundation; Filing of Food Additive Petition →
drugfood
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Jul 29, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Notification Procedures for Statements of Dietary Supplements →
drugfood
Aug 28, 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.