[ 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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability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
Dec 29, 2025NoticeAuthorization of Emergency Use for Two Animal Drugs for the Treatment of New World Screwworm; Availability →
drugfoodcosmetics
—
Dec 29, 2025NoticeRoundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products; Notice of Meeting; Establishment of a Public Docket; Request for Comments →
drugdevicefood
Dec 29, 2025
Dec 29, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; LEQEMBI →
drugbiologicsfood
Feb 27, 2026
Dec 23, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance of Medical Devices →
drugdevicefood
Jan 21, 2026
Dec 23, 2025NoticeFormal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability →
drugfoodcosmetics
—
Dec 19, 2025RuleMedical Devices; Neurological Devices; Classification of the Electrical Tongue Nerve Stimulator To Treat Motor Deficits →
drugdevicefood
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Dec 19, 2025NoticeAgency Information Collection Activities; Announcement of Office of Management and Budget Approvals →
drugfood
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Dec 19, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Required Warnings for Cigarette Packages and Advertisements →
drugdevicefood
Feb 17, 2026
Dec 19, 2025NoticeDetermination That DEXCHLORPHENIRAMINE MALEATE (Dexchlorpheniramine Maleate, Oral Syrup, 2 Milligrams/5 Milliliters) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness →
drugfood
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Dec 19, 2025NoticeNotice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) →
drugfoodcosmetics
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Dec 19, 2025NoticeIssuance of Priority Review Voucher; Rare Pediatric Disease Product; FORZINITY (Elamipretide) →
drugfoodcosmetics
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Dec 19, 2025NoticeDetermination That EFFEXOR XR (Venlafaxine Hydrochloride) Extended-Release Capsule, 100 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness →
drugfood
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Dec 19, 2025NoticeProcesses and Practices Applicable to Bioresearch Monitoring Inspections; Guidance for Industry; Availability →
drugfood
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Dec 18, 2025NoticeUse of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability →
drugdevicefood
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Dec 18, 2025NoticeQuestions and Answers Regarding Mandatory Cosmetics Recalls: Draft Guidance for Industry; Availability →
drugdevicefood
Feb 17, 2026
Dec 16, 2025NoticeInvestigator Responsibilities-Safety Reporting for Investigational Drugs and Devices; Guidance for Investigators, Industry, and Institutional Review Boards; Availability →
drugdevicefood
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Dec 16, 2025NoticeSponsor Responsibilities-Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Bioequivalence Studies; Guidance for Industry; Availability →
drugdevicefood
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Dec 12, 2025NoticeAmending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use →
drugfood
Jan 26, 2026
Dec 12, 2025NoticeBiosimilar User Fee Act; Stakeholder Consultation Meetings on Biosimilar User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate →
drugbiologicsdevice
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Dec 12, 2025NoticePfizer Inc., U.S. Agent for King Pharmaceuticals LLC, et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications →
drugfood
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Dec 12, 2025NoticeDetermination That BACTROBAN (Mupirocin) Nasal Ointment, 2%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness →
drugfood
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Dec 12, 2025NoticeDetermination That DEMEROL (Meperidine Hydrochloride) Tablet, 100 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness →
drugfood
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Dec 12, 2025NoticeDetermination That LUNELLE (Estradiol Cypionate and Medroxyprogesterone Acetate) Injectable, 5 Milligrams/0.5 Milliliter and 25 Milligrams/0.5 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness →
drugfood
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Dec 12, 2025NoticeDetermination That ZANTAC (Ranitidine Hydrochloride) Injection, Equivalent to 25 Milligrams Base/Milliliter, Has Not Been Withdrawn From Sale for Reasons of Safety or Effectiveness →
drugdevicefood
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Dec 11, 2025NoticeFood and Drug Administration Expert Panel on Testosterone Replacement Therapy for Men; Request for Information →
drugfood
Feb 9, 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.