[ 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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability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Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability
Reset
681 matching documents
PublishedTypeTitleIndustryComments close
Apr 20, 2026NoticePotential New Indication for Testosterone Replacement Therapy
drugdevicefood
Apr 20, 2026NoticeEstablishing Impurity Specifications for Antibiotics; Draft Guidance for Industry; Availability
drugfood
Jun 22, 2026
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 17, 2026NoticeAuthorization of Emergency Use for Four Animal Drugs for the Treatment of New World Screwworm; Availability
drugfoodcosmetics
Apr 17, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Radioactive Drug Research Committees
drugdevicefood
Jun 16, 2026
Apr 17, 2026NoticeAnimal Generic Drug User Fee Act; Public Meeting; Request for Comments
drugfood
Apr 17, 2026NoticeAnimal Drug User Fee Act; Public Meeting; Request for Comments
drugfoodveterinary
Apr 16, 2026RulePhysical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators
drugdevicefood
Apr 16, 2026NoticeNotice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted)
drugbiologicsfood
Apr 16, 2026RuleMedical Devices; Ear, Nose, and Throat Devices; Classification of the Transcutaneous Electrical Nerve Stimulator for the Relief of Congestion
drugdevicefood
Apr 16, 2026RuleNew Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address
drugfoodveterinary
Apr 16, 2026NoticeInternational Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Stability Testing for Medicated Premixes (Revision 1); Draft Guidance for Industry; Availability
drugfoodveterinary
Jun 15, 2026
Apr 16, 2026RuleMedical Devices; Orthopedic Devices; Classification of the Manual Surgical Instrument for Appropriate Patient Selection for Orthopedic Implant
drugdevicefood
Apr 16, 2026NoticePharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List
drugfood
Apr 16, 2026NoticeNotice of Approval of Product Under Priority Review Voucher; Material Threat Medical Countermeasure Priority Review Voucher; MRESVIA (Respiratory Syncytial Virus Vaccine)
drugbiologicsfood
Apr 16, 2026NoticeNotice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; MRESVIA (Respiratory Syncytial Virus Vaccine)
drugbiologicsfood
Apr 16, 2026NoticeNotice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; MNEXSPIKE (COVID-19 Vaccine, mRNA)
drugbiologicsfood
Apr 16, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Importation of Prescription Drugs
drugdevicefood
Jun 15, 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, 2026NoticeDetermination That CHEWTADZY (Tadalafil) Chewable Tablets, 5 Milligrams, 10 Milligrams, 20 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
drugfood
Apr 16, 2026NoticeDetermination That REVIA (Naltrexone Hydrochloride) Tablets, 50 Milligrams Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
drugfood
Apr 15, 2026NoticeIncreasing Access to Nonprescription Drugs; Public Meeting; Request for Comments
drugfood
May 8, 2026
Apr 15, 2026NoticeFinancial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; Public Meeting; Request for Comments
drugfood
Jul 23, 2026
Apr 15, 2026NoticeSafety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability
drugbiologicsdevice
Jul 14, 2026
Page 10 of 28
← PrevNext →

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.