[ 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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability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 11, 2026NoticeFlavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications-Considerations Related to Youth Risk; Draft Guidance for Industry; Availability
drugdevicefood
May 11, 2026
Mar 10, 2026NoticeNew and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act; Draft Guidance for Industry; Availability
drugbiologicsfood
May 11, 2026
Mar 10, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; AURORA EV-ICD
Mar 9, 2026NoticeResponding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry; Availability
drugbiologicsfood
May 8, 2026
Mar 9, 2026NoticeAspen Global Inc. c/o Lachman Consultant Services, Inc., et al.; Withdrawal of Approval of 46 New Drug Applications
drugfood
Mar 9, 2026NoticeOncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-New Drug Application 220359, for Camizestrant Tablets; Supplemental New Drug Application (sNDA) 218197/S-004, for Truqap (Capivasertib) Tablets
drugfood
Mar 6, 2026NoticeDeveloping Specifications for In-Home Disposal Systems for Opioid Analgesics Dispensed in an Outpatient Setting; Establishment of a Public Docket; Request for Comments
drugfood
Apr 6, 2026
Mar 6, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ENSACOVE
drugfood
May 5, 2026
Mar 5, 2026RuleRevising the National Drug Code Format and Drug Label Barcode Requirements
drugfood
Mar 4, 2026NoticeNew Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
drugfood
May 4, 2026
Mar 4, 2026Proposed RuleKemin Industries, Inc.; Filing of Food Additive Petition (Animal Use)
drugfood
Apr 3, 2026
Mar 4, 2026Proposed RuleEcoflora Cares; Filing of Color Additive Petition
drugfood
Mar 4, 2026NoticeM14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-Interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines; International Council for Harmonisation; Guidance for Industry; Availability
drugbiologicsdevice
Mar 4, 2026NoticeE2D(R1) Postapproval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports; International Council for Harmonisation; Guidance for Industry; Availability
drugfood
Mar 3, 2026NoticeRecommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments
drugfood
Jun 1, 2026
Feb 27, 2026NoticeInternational Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Scheduling Recommendations; N-Pyrrolidino Isotonitazene; N-Desethyl Etonitazene; Coca Leaf; MDMB-FUBINACA; Request for Comments
drugfood
Mar 5, 2026
Feb 27, 2026NoticeIssuance of Priority Review Voucher; Rare Pediatric Disease Product; ZYCUBO (Copper Histidinate)
drugfoodcosmetics
Feb 27, 2026NoticeProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
drugdevicefood
Apr 28, 2026
Feb 27, 2026NoticeFiscal Year 2026 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments
drugfood
Jul 10, 2026
Feb 26, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records
drugdevicefood
Mar 30, 2026
Feb 26, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; LIMFLOW SYSTEM
drugdevicefood
Apr 27, 2026
Feb 26, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; MERIT MEDICAL WRAPSODY
drugdevicefood
Apr 27, 2026
Feb 26, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; REVUFORJ
drugfood
Apr 27, 2026
Feb 26, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ORLYNVAH
drugfood
Apr 27, 2026
Feb 26, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; AEROPACE
drugdevicefood
Apr 27, 2026
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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.