[ 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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability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
Mar 30, 2026Proposed RuleMicrobiology Devices; Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests →
drugdevicefood
May 29, 2026
Mar 26, 2026NoticeElite Laboratories, Inc., et al.; Withdrawal of Approval of 72 Abbreviated New Drug Applications; Correction →
drugfood
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Mar 25, 2026RuleGeneral and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Software-Aided Adjunctive Diagnostic Devices for Use on Skin Lesions by Physicians Trained in the Diagnosis and Management of Skin Cancer →
drugdevicefood
—
Mar 24, 2026RuleListing of Color Additive Exempt From Certification; Beetroot Red; Delay of Effective Date →
drugfoodcosmetics
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Mar 24, 2026RuleListing of Color Additive Exempt From Certification; Spirulina Extract; Delay of Effective Date →
drugfoodcosmetics
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Mar 23, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Advisory Committees →
drugdevicefood
May 22, 2026
Mar 23, 2026NoticeCommissioner's National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for Comments →
drugbiologicsdevice
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Mar 23, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Reporting Associated With Animal Drug and Animal Generic Drug User Fees →
drugdevicefood
May 22, 2026
Mar 19, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notifications Submission →
drugdevicefood
May 18, 2026
Mar 19, 2026NoticeGeneral Considerations for the Use of New Approach Methodologies in Drug Development; Draft Guidance for Industry; Availability →
drugdevicefood
May 18, 2026
Mar 18, 2026Proposed RuleEffective Date of Requirement for Premarket Approval Applications for Blood Irradiators Intended To Prevent Metastasis →
drugbiologicsdevice
May 18, 2026
Mar 18, 2026NoticeAdvisory Committee; Obstetrics, Reproductive and Urologic Drugs Advisory Committee; Renewal →
drugfood
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Mar 18, 2026Proposed RuleMedical Devices; Radiology Devices; Classification of Blood Irradiators →
drugbiologicsdevice
May 18, 2026
Mar 18, 2026NoticeLabeling and Preventing Cross-Contact of Gluten for Packaged Foods; Request for Information; Extension of Comment Period →
drugfood
Apr 22, 2026
Mar 18, 2026NoticeDetermination That METHERGINE (Methylergonovine Maleate) Injection, 0.2 Milligram/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness →
drugfood
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Mar 18, 2026NoticePhysicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in Abbreviated New Drug Applications; Guidance for Industry, Availability →
drugdevicefood
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Mar 18, 2026NoticeOver-the-Counter Monograph Drug Facility Fee Rates for Fiscal Year 2026 →
drugfoodcosmetics
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Mar 18, 2026NoticePreparation for International Cooperation on Cosmetics Regulation Twentieth Annual Meeting (ICCR-20); Request for Comments →
drugfoodcosmetics
May 18, 2026
Mar 16, 2026Proposed RuleGeneral and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products; Withdrawal of Proposed Rule →
drugdevicefood
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Mar 13, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Animal Food and Egg Regulatory Program Standards →
drugfoodveterinary
Apr 13, 2026
Mar 13, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mammography Standards Quality Act Requirements →
drugfood
Apr 13, 2026
Mar 13, 2026NoticeNotice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; EYLEA HD (aflibercept) →
drugfoodcosmetics
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Mar 13, 2026NoticeMedical Devices With Indications Associated With Weight Loss-Premarket Considerations; Guidance for Industry and Food and Drug Administration Staff; Availability →
drugdevicefood
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Mar 13, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements →
drugdevicefood
May 12, 2026
Mar 12, 2026NoticeWatson Laboratories, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications →
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.