[ 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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability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
Apr 13, 2026NoticeDetermination That BILTRICIDE (Praziquantel) Oral Tablet, 600 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness →
drugfood
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Apr 10, 2026NoticeGlaxoSmithKline; Withdrawal of Approval of a New Drug Application for Wellcovorin (Leucovorin Calcium) Tablets, EQ 5 mg Base and EQ 25 mg Base →
drugfood
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Apr 10, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices →
drugdevicefood
Jun 9, 2026
Apr 10, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503 →
drugdevicefood
Jun 9, 2026
Apr 10, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Color Additive Certification →
drugdevicefood
Jun 9, 2026
Apr 7, 2026NoticeIssuance of Priority Review Voucher; Rare Pediatric Disease Product; LOARGYS (pegzilarginase-nbln) →
drugfoodcosmetics
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Apr 7, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Administrative Practices and Procedures; Formal Hearings →
drugdevicefood
Jun 8, 2026
Apr 6, 2026NoticeDetermination That STRATTERA (Atomoxetine Hydrochloride) Capsules 5 Milligrams, 10 Milligrams, 18 Milligrams, 25 Milligrams, 40 Milligrams, 60 Milligrams, 80 Milligrams, and 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness →
drugfood
—
Apr 6, 2026NoticeElectronic Submission of Postmarketing Individual Case Safety Reports to the Food and Drug Administration Adverse Event Monitoring System Using International Council of Harmonisation E2B(R3) Data Standards; Regional Data Elements and Implementation Schedule →
drugbiologicsfood
Oct 1, 2026
Apr 3, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; INJECTAFER →
drugfood
Jun 2, 2026
Apr 3, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ZIIHERA →
drugbiologicsfood
Jun 2, 2026
Apr 3, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; HYMPAVZI →
drugbiologicsfood
Jun 2, 2026
Apr 3, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Customer/Partner Customer Service Satisfaction Surveys →
drugdevicefood
Jun 2, 2026
Apr 3, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ENCELTO →
drugbiologicsfood
Jun 2, 2026
Apr 3, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; VYLOY →
drugbiologicsfood
Jun 2, 2026
Apr 3, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ENFLONSIA →
drugbiologicsfood
Jun 2, 2026
Apr 3, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; EMRELIS →
drugbiologicsfood
Jun 2, 2026
Apr 2, 2026NoticeIssuance of Priority Review Voucher; Rare Pediatric Disease Product; KRESLADI (marnetegragene autotemcel) →
drugfoodcosmetics
—
Apr 1, 2026NoticeIssuance of Priority Review Voucher; Rare Pediatric Disease Product; YUVIWEL (navepegritide) →
drugfoodcosmetics
—
Apr 1, 2026Proposed RuleFiling of Color Additive Petition From the International Association of Color Manufacturers; Request To Amend the Color Additive Regulations To Remove the Solvents Methylene Chloride, Trichloroethylene, and Ethylene Dichloride →
drugfood
Jun 1, 2026
Apr 1, 2026NoticeConsideration of Acceptable Market Name Change for Certain Rockfish (Sebastes spp.); Request for Information →
drugfood
May 1, 2026
Apr 1, 2026NoticeDetermination That INAPSINE (Droperidol) Injection, 2.5 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness →
drugfood
—
Mar 31, 2026NoticeAdvancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products; Request for Information and Comments →
drugbiologics
Jun 1, 2026
Mar 31, 2026NoticeNotice of Decision on a Hearing Request Regarding a Proposal To Refuse To Approve a New Drug Application for TRADIPITANT Capsules →
drugfood
Mar 26, 2026
Mar 30, 2026NoticeIncorporating Voluntary Patient Preference Information Over the Total Product Life Cycle; Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties; Availability →
drugdevicefood
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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.