[ 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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability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
Apr 29, 2026NoticeAI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information →
drugfood
May 29, 2026
Apr 27, 2026NoticeAdvisory Committee; Anesthetic and Analgesic Drug Products Advisory Committee; Renewal →
drugfood
—
Apr 27, 2026NoticeVaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-United States (U.S.) 2026-2027 Formula for COVID-19 Vaccine Composition →
drugbiologicsfood
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Apr 24, 2026NoticeReport on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability →
drugbiologicsdevice
—
Apr 24, 2026NoticeEgis Pharmaceuticals Limited, et al.; Withdrawal of Approval of Three Abbreviated New Drug Applications →
drugfood
—
Apr 23, 2026NoticeKimberly Schaff Kiehl: Final Debarment Order →
drugfoodcosmetics
—
Apr 23, 2026NoticeHarmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke; Established List Additions and Request for Comments →
drugfoodcosmetics
May 26, 2026
Apr 23, 2026NoticeCommissioner's National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for Comments; Amendment →
drugfood
—
Apr 22, 2026RuleMedical Devices; Anesthesiology Devices; Classification of the Device for Sleep Apnea Testing Based on Mandibular Movement →
drugdevicefood
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Apr 22, 2026RuleMedical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Setmelanotide Eligibility Gene Variant Detection System →
drugdevicefood
—
Apr 22, 2026RuleMedical Devices; Ophthalmic Devices; Classification of the Digital Therapy Device for Amblyopia →
drugdevicefood
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Apr 22, 2026RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Alzheimer's Disease Pathology Assessment Test →
drugdevicefood
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Apr 20, 2026NoticeEstablishing Impurity Specifications for Antibiotics; Draft Guidance for Industry; Availability →
drugfood
Jun 22, 2026
Apr 20, 2026NoticeCompliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators; Draft Guidance for Industry and Food and Drug Administration Staff; Availability →
drugdevicefood
Jun 22, 2026
Apr 20, 2026NoticePotential New Indication for Testosterone Replacement Therapy →
drugdevicefood
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Apr 17, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Radioactive Drug Research Committees →
drugdevicefood
Jun 16, 2026
Apr 17, 2026NoticeAuthorization of Emergency Use for Four Animal Drugs for the Treatment of New World Screwworm; Availability →
drugfoodcosmetics
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Apr 17, 2026NoticeAnimal Generic Drug User Fee Act; Public Meeting; Request for Comments →
drugfood
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Apr 17, 2026NoticeAnimal Drug User Fee Act; Public Meeting; Request for Comments →
drugfoodveterinary
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Apr 17, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed →
drugdevicefood
Jun 16, 2026
Apr 16, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; UNLOXCYT →
drugbiologicsfood
Jun 15, 2026
Apr 16, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs →
drugdevicefood
Jun 15, 2026
Apr 16, 2026NoticeNotice of Approval of Product Under Priority Review Voucher; Material Threat Medical Countermeasure Priority Review Voucher; MRESVIA (Respiratory Syncytial Virus Vaccine) →
drugbiologicsfood
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Apr 16, 2026NoticeDetermination That CHEWTADZY (Tadalafil) Chewable Tablets, 5 Milligrams, 10 Milligrams, 20 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness →
drugfood
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Apr 16, 2026NoticeDetermination That REVIA (Naltrexone Hydrochloride) Tablets, 50 Milligrams 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.