[ 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
26
Proposed rules
32
Open for comment
latest published 2026-07-29 · source: U.S. Federal Register (FDA)
⏳ CLOSING SOONEST · OPEN FOR PUBLIC COMMENT
COMMENTS CLOSE Jul 29, 2026
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Minor Use and Minor Species
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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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
Reset
32 matching documents
PublishedTypeTitleIndustryComments close
Jul 29, 2026NoticeProduct-Specific Guidances; Revised Draft Guidances for Industry; Availability
drugdevicefood
Sep 28, 2026
Jul 28, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Expanded Access to Investigational Drugs for Treatment Use
drugdevicefood
Sep 28, 2026
Jul 27, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees
drugfood
Aug 26, 2026
Jul 23, 2026Proposed RuleProposal To Revoke the Color Additive Listing for Use of Citrus Red No. 2 on the Skins of Mature Oranges
drugfood
Aug 24, 2026
Jul 22, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notifications Submission
drugdevicefood
Aug 21, 2026
Jul 21, 2026NoticeExpedited Investigational New Drug Pilot Program; Request for Information; Extension of the Comment Period
drugfood
Aug 24, 2026
Jul 17, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Voluntary Improvement Program
drugdevicefood
Sep 15, 2026
Jul 17, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Accreditation Scheme for Conformity Assessment Program
drugdevicefood
Sep 15, 2026
Jul 17, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Devices: (Medical Product Safety Network (MedSun))
drugdevicefood
Sep 15, 2026
Jul 17, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Cosmetic Products
drugdevicefood
Sep 15, 2026
Jul 17, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Voluntary National Retail Food Regulatory Program Standards
drugdevicefood
Sep 15, 2026
Jul 17, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements
drugdevicefood
Sep 15, 2026
Jul 13, 2026Proposed RuleDrug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
drugfood
Sep 11, 2026
Jul 6, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Approval of Medical Devices
drugdevicefood
Aug 5, 2026
Jul 6, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Practices and Procedures; Formal Hearings
drugfood
Aug 5, 2026
Jul 6, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Biologics License Applications, Procedures and Requirements
drugbiologicsdevice
Sep 4, 2026
Jul 1, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medication Guides for Prescription Drug Products
drugfood
Jul 31, 2026
Jun 29, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Minor Use and Minor Species
drugfoodveterinary
Jul 29, 2026
Jun 29, 2026Proposed RuleEstablishment Registration and Product Listing for Tobacco Products
drugfood
Sep 14, 2026
Jun 29, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; VYALEV
drugfood
Dec 28, 2026
Jun 26, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Time and Extent Applications for Nonprescription Drug Products
drugdevicefood
Aug 25, 2026
Jun 24, 2026NoticeMaster Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Availability
drugbiologicsfood
Aug 24, 2026
Jun 24, 2026NoticeDemonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Revised Draft Guidance for Industry; Availability
drugbiologicsfood
Sep 22, 2026
Jun 23, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Potential Tobacco Product Violations Reporting Form
drugdevicefood
Aug 24, 2026
Jun 18, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals
drugdevicefood
Aug 17, 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.