[ 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.

636
Documents tracked (12 mo)
99
Rules
24
Proposed rules
31
Open for comment
latest published 2026-07-29 · source: U.S. Federal Register (FDA)
⏳ CLOSING SOONEST · OPEN FOR PUBLIC COMMENT
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 Jul 31, 2026
Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability
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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability
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669 matching documents
PublishedTypeTitleIndustryComments close
May 22, 2026NoticeM11 Clinical Electronic Structured Harmonised Protocol (CeSHarP); International Council for Harmonisation; Guidance for Industry; Availability →
drugdevicefood
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May 21, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Required Warnings for Cigarette Packages and Advertisements →
drugfood
Jun 22, 2026
May 21, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Active Pharmaceutical Ingredients) and the Advanced Manufacturing Technologies Designation Program →
drugdevicefood
Jun 22, 2026
May 21, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience/Events With Approved New Animal Drugs →
drugfoodveterinary
Jun 22, 2026
May 21, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Patent Term Restoration; Due Diligence Petitions; Filing, Format, and Content of Petitions →
drugfood
Jun 22, 2026
May 15, 2026NoticeOscar Bobo: Final Debarment Order →
drugfoodcosmetics
—
May 13, 2026NoticeAzodicarbonamide (ADA); Request for Information →
drugfood
Jul 13, 2026
May 13, 2026NoticeButylated Hydroxytoluene (BHT); Request for Information →
drugfood
Jul 13, 2026
May 13, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; The Real Cost Campaign Outcomes Evaluation Study: Cohort 3 →
drugfood
Jun 12, 2026
May 13, 2026NoticeBiomarker Incubator: Urinary Kidney Safety Biomarkers; Request for Information →
drugfood
Jul 13, 2026
May 13, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting →
drugbiologicsdevice
Jul 13, 2026
May 13, 2026NoticeModified Risk Tobacco Product Application: Renewal Applications for VLN® King and VLN® Menthol King, Cigarette Products Submitted by 22nd Century Group Inc. →
drugfood
May 13, 2026
May 12, 2026NoticeDrug Repurposing for Unmet Medical Needs; Request for Information →
drugfood
Jun 11, 2026
May 12, 2026RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microorganism Nucleic Acids and Resistance Markers From Patients With Suspected Orthopedic Infection →
drugdevicefood
—
May 12, 2026NoticeEnforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization; Guidance for Industry; Availability →
drugdevicefood
—
May 12, 2026Notice21st Century Cures Act: Annual Compilation of Notices of Updates From the Susceptibility Test Interpretive Criteria web page →
drugfood
—
May 11, 2026NoticeAnimal Generic Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Generic Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intent To Participate →
drugdevicefood
—
May 11, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications On Medical Devices and Radiation-Emitting Products →
drugdevicefood
Jun 10, 2026
May 11, 2026NoticeIssuance of Priority Review Voucher; Rare Pediatric Disease Product; AVLAYAH (tividenofusp alfa-eknm) →
drugfoodcosmetics
—
May 11, 2026NoticeClostridioides Difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, or Prevention; Guidance for Industry; Availability →
drugfood
—
May 11, 2026NoticePostapproval Pregnancy Safety Studies; Guidance for Industry; Availability →
drugbiologicsdevice
—
May 11, 2026NoticeAnimal Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intent To Participate →
drugdevicefood
—
May 11, 2026NoticePulmonary Tuberculosis: Developing Drugs for Treatment; Guidance for Industry; Availability →
drugfood
—
May 8, 2026RuleMedical Devices; Obstetrical and Gynecological Devices; Classification of the External Condom for Anal Intercourse or Vaginal Intercourse →
drugdevicefood
—
May 8, 2026NoticeDetermination That Leucovorin Calcium, Oral Solution, Equivalent to 60 Milligrams Base/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness →
drugfood
—
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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.