[ 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.
644
Documents tracked (12 mo)
93
Rules
28
Proposed rules
56
Open for comment
latest published 2026-09-11 · source: U.S. Federal Register (FDA)
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Showing the 300 most recent of 2,168 tracked documents. Filter below; every document also has its own page.
300 documents in library
NoticeSep 11, 2026
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed →DrugFoodCosmeticsVeterinary
Comments close Oct 13, 2026
NoticeSep 11, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Tracking →DrugDeviceFood
Comments close Nov 10, 2026
RuleSep 10, 2026
Medical Devices; Radiology Devices; Classification of the Vaginal Hydrogel Packing System →DrugDeviceFood
Proposed RuleSep 10, 2026
Green Innovation GmbH; Withdrawal of Food Additive Petition (Animal Use) →DrugDeviceFood
NoticeSep 10, 2026
Fee Rate for Using a Priority Review Voucher in Fiscal Year 2027 →DrugBiologicsFoodCosmetics
NoticeSep 9, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products →DrugBiologicsDeviceFood
Comments close Nov 9, 2026
NoticeSep 9, 2026
Determination of Regulatory Review Period for Purposes of Patent Extension; ANKTIVA →DrugBiologicsFood
Comments close Mar 8, 2027
NoticeSep 9, 2026
Determination of Regulatory Review Period for Purposes of Patent Extension; ANZUPGO →DrugFood
Comments close Mar 8, 2027
NoticeSep 9, 2026
Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEMBRY →DrugBiologicsFood
Comments close Mar 8, 2027
NoticeSep 4, 2026
Advancing Development of Botanical Drug Products; Request for Information →DrugFoodCosmetics
Comments close Nov 3, 2026
NoticeSep 2, 2026
Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage; Draft Guidance for Industry; Availability →DrugBiologicsDeviceFood
Comments close Dec 1, 2026
NoticeSep 2, 2026
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2); Guidance for Industry; Availability →DrugDeviceFoodVeterinary
NoticeSep 2, 2026
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1); Guidance for Industry; Availability →DrugDeviceFoodVeterinary
NoticeSep 2, 2026
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; GENGLYCOS (parisglasgene brecaparvovec-opnr) →DrugFoodCosmetics
NoticeAug 31, 2026
Authorization of Emergency Use for Three Animal Drugs for the Prevention and Treatment of New World Screwworm; Availability →DrugFoodCosmeticsVeterinary
NoticeAug 31, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Removals and Corrections →DrugDeviceFood
Comments close Oct 30, 2026
NoticeAug 31, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated Fees →DrugDeviceFoodCosmetics
Comments close Oct 30, 2026
NoticeAug 31, 2026
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Potential Tobacco Product Violations Reporting Form →DrugFood
Comments close Sep 30, 2026
NoticeAug 28, 2026
Compounding Animal Drugs From Bulk Drug Substances: Compounding Under CGMP in Federally-Registered Facilities; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request →DrugFoodVeterinary
Comments close Nov 27, 2026
NoticeAug 28, 2026
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Associated With Animal Drug and Animal Generic Drug User Fees →DrugFoodVeterinary
Comments close Sep 28, 2026
NoticeAug 28, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers →DrugDeviceFood
Comments close Oct 27, 2026
NoticeAug 28, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups and Interviews as Used by the Food and Drug Administration →DrugDeviceFood
Comments close Oct 27, 2026
NoticeAug 28, 2026
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Importation of Prescription Drugs →DrugFood
Comments close Sep 28, 2026
NoticeAug 28, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; Qualitative Feedback on Agency Service Delivery →DrugDeviceFood
Comments close Oct 27, 2026
Closed Sep 3, 2026
NoticeAug 26, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health →DrugDeviceFood
Comments close Oct 26, 2026
NoticeAug 24, 2026
Evaluation of Therapeutic Equivalence; Guidance for Industry; Availability →DrugFoodCosmetics
NoticeAug 24, 2026
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability →DrugDeviceFood
Comments close Oct 23, 2026
NoticeAug 24, 2026
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 066 →DrugDeviceFood
Closed Aug 24, 2026
NoticeAug 20, 2026
Frequently Asked Questions-Developing Potential Cellular and Gene Therapy Products; Final Guidance for Industry; Availability →DrugBiologicsDeviceFood
NoticeAug 20, 2026
Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee; Renewal →DrugFood
NoticeAug 20, 2026
Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry; Availability →DrugBiologicsDeviceFood
Comments close Nov 18, 2026
NoticeAug 20, 2026
Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee; Renewal →DrugFood
Proposed RuleAug 19, 2026
International Association of Color Manufacturers; Filing of Color Additive Petition →DrugFood
Comments close Sep 18, 2026
RuleAug 19, 2026
Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate →DrugFood
Comments close Sep 18, 2026
NoticeAug 18, 2026
Determining Whether To Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; Availability →DrugFoodCosmetics
Comments close Oct 19, 2026
NoticeAug 18, 2026
Testosterone Use in Menopausal Women; Public Workshop; Request for Comments →DrugBiologicsDeviceFood
NoticeAug 17, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food →DrugDeviceFood
Comments close Oct 16, 2026
NoticeAug 17, 2026
Determination of Regulatory Review Period for Purposes of Patent Extension; BIZENGRI →DrugBiologicsFood
Comments close Oct 16, 2026
Proposed RuleAug 17, 2026
Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments →DrugDeviceFood
Comments close Oct 16, 2026
NoticeAug 17, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; Imports and Electronic Import Entries →DrugDeviceFood
Comments close Oct 16, 2026
NoticeAug 17, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements →DrugFood
Comments close Sep 16, 2026
NoticeAug 17, 2026
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals →DrugFood
Proposed RuleAug 17, 2026
Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer →DrugDeviceFood
Comments close Oct 16, 2026
NoticeAug 17, 2026
Type VII Veterinary Master File for Research and Development and Risk Reviews; Guidance for Industry; Availability →DrugBiologicsFoodVeterinary
NoticeAug 14, 2026
Container Closure Systems for Human Drugs and Biological Products; Draft Guidance for Industry; Availability →DrugBiologicsDeviceFood
Comments close Oct 13, 2026
NoticeAug 14, 2026
Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments →DrugFoodCosmetics
RuleAug 12, 2026
Guide To Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce; Guidance for Industry; Availability →DrugBiologicsFood
Comments close Dec 9, 2026
NoticeAug 11, 2026
Reauthorization of the Generic Drug User Fee Amendments; Public Meeting; Request for Comments →DrugFoodCosmetics
Comments close Oct 17, 2026
NoticeAug 10, 2026
Determination of Regulatory Review Period for Purposes of Patent Extension; DAYVIGO →DrugFood
Comments close Feb 8, 2027
Proposed RuleAug 10, 2026
Radiology Devices; Reclassification of Digital Breast Tomosynthesis System →DrugDeviceFood
Comments close Oct 9, 2026
NoticeAug 10, 2026
Determination of Regulatory Review Period for Purposes of Patent Extension; BRINSUPRI →DrugFood
Comments close Feb 8, 2027
NoticeAug 6, 2026
Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to their Microbiological Effects on Bacteria of Human Health Concern; Guidance for Industry; Availability →DrugBiologicsFoodVeterinary
RuleAug 6, 2026
Medical Devices; Radiology Devices; Classification of the Fludeoxyglucose F18-Guided Radiation Therapy System →DrugDeviceFood
NoticeAug 6, 2026
Authorization of Emergency Use of an In Vitro Diagnostic Device in Response to an Outbreak of Mpox; Availability →DrugDeviceFoodCosmetics
NoticeAug 5, 2026
Establishment of a Quantitative Medicine Innovation Network: Scope, Feasibility, and Opportunities; Request for Information →DrugFood
Comments close Nov 3, 2026
RuleAug 5, 2026
Micro-Tracers, Inc.; Response to Objections and Requests for a Public Hearing →DrugDeviceFood
NoticeAug 5, 2026
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Advisory Committees →DrugFood
Closed Sep 4, 2026
NoticeAug 3, 2026
Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs; Guidance for Industry; Availability →DrugDeviceFood
NoticeAug 3, 2026
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Revised Draft Guidance for Industry; Availability →DrugDeviceFood
Comments close Oct 2, 2026
Proposed RuleAug 3, 2026
Modification of Certain Terminology in Title 21; Reopening of the Comment Period →DrugBiologicsFood
Comments close Oct 2, 2026
NoticeAug 3, 2026
Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Draft Guidance for Industry; Availability →DrugDeviceFood
Comments close Oct 2, 2026
NoticeJul 30, 2026
Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027 →DrugFoodCosmetics
NoticeJul 30, 2026
Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2027 →DrugFoodCosmetics
NoticeJul 30, 2026
Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2027 →DrugFoodCosmetics
NoticeJul 30, 2026
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2027 →DrugFoodCosmeticsVeterinary
Comments close Oct 1, 2026
NoticeJul 30, 2026
Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2027 →DrugFoodCosmeticsVeterinary
Comments close Oct 1, 2026
NoticeJul 30, 2026
Food Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2027 →DrugFoodCosmetics
NoticeJul 30, 2026
Butylated Hydroxytoluene (BHT); Request for Information; Reopening of Comment Period →DrugFood
Closed May 13, 2026
RuleJul 29, 2026
Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy →DrugDeviceFood
NoticeJul 29, 2026
Product-Specific Guidances; Revised Draft Guidances for Industry; Availability →DrugDeviceFood
Comments close Sep 28, 2026
NoticeJul 28, 2026
Fee Rate for Using a Priority Review Voucher in Fiscal Year 2026; Correction →DrugBiologicsDeviceFood
NoticeJul 28, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; Expanded Access to Investigational Drugs for Treatment Use →DrugDeviceFood
Comments close Sep 28, 2026
NoticeJul 27, 2026
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees →DrugFood
Closed Aug 26, 2026
Proposed RuleJul 24, 2026
Evonik Corporation, Filing of Food Additive Petition (Animal Use) →DrugFood
RuleJul 24, 2026
Medical Devices; Orthopedic Devices; Classification of the Intraoperative Surgical Angle Measurement Tool →DrugDeviceFood
Proposed RuleJul 23, 2026
Proposal To Revoke the Color Additive Listing for Use of Citrus Red No. 2 on the Skins of Mature Oranges →DrugFood
Closed Aug 24, 2026
NoticeJul 22, 2026
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notifications Submission →DrugDeviceFood
Closed Aug 21, 2026
NoticeJul 21, 2026
Expedited Investigational New Drug Pilot Program; Request for Information; Extension of the Comment Period →DrugFood
Closed Aug 24, 2026
NoticeJul 17, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Voluntary Improvement Program →DrugDeviceFood
Comments close Sep 15, 2026
NoticeJul 17, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary National Retail Food Regulatory Program Standards →DrugDeviceFood
Comments close Sep 15, 2026
NoticeJul 17, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; Accreditation Scheme for Conformity Assessment Program →DrugDeviceFood
Comments close Sep 15, 2026
NoticeJul 17, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements →DrugDeviceFood
Comments close Sep 15, 2026
NoticeJul 17, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Cosmetic Products →DrugDeviceFoodCosmetics
Comments close Sep 15, 2026
NoticeJul 17, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Devices: (Medical Product Safety Network (MedSun)) →DrugDeviceFood
Comments close Sep 15, 2026
NoticeJul 16, 2026
Process for FDA Data Requests To Inform Certain Over-the-Counter Monograph Drug Activities; Procedure →DrugDeviceFood
NoticeJul 14, 2026
Topical Dermatologic Corticosteroids: In Vivo Bioequivalence; Guidance for Industry; Availability →DrugDeviceFood
NoticeJul 14, 2026
Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs →DrugFoodCosmetics
NoticeJul 14, 2026
Psychedelic Drugs: Considerations for Clinical Investigations; Guidance for Industry; Availability →DrugFood
Proposed RuleJul 13, 2026
Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments →DrugFood
Closed Sep 11, 2026
NoticeJul 8, 2026
Medical Device User Fee Amendments; Public Meeting; Request for Comments →DrugDeviceFoodCosmetics
NoticeJul 6, 2026
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Approval of Medical Devices →DrugDeviceFood
Closed Aug 5, 2026
NoticeJul 6, 2026
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Practices and Procedures; Formal Hearings →DrugFood
Closed Aug 5, 2026
NoticeJul 6, 2026
Expedited Investigational New Drug Pilot Program; Request for Information; Correction →DrugFood
NoticeJul 6, 2026
Endo Operations Limited, et al.; Withdrawal of Approval of 34 New Drug Applications →DrugFood
NoticeJul 6, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; Biologics License Applications, Procedures and Requirements →DrugBiologicsDeviceFood
Closed Sep 4, 2026
NoticeJul 1, 2026
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medication Guides for Prescription Drug Products →DrugFood
Closed Jul 31, 2026
RuleJun 30, 2026
Medical Devices; General and Plastic Surgery Devices; Classification of the Skin Patch for Treatment of Hyperhidrosis →DrugDeviceFood
RuleJun 30, 2026
Medical Devices; Anesthesiology Devices; Classification of the Monitor for Opioid Induced Impairment of Oxygenation →DrugDeviceFood
NoticeJun 29, 2026
Determination of Regulatory Review Period for Purposes of Patent Extension; VYALEV →DrugFood
Comments close Dec 28, 2026
NoticeJun 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 →DrugFoodVeterinary
Closed Jul 29, 2026
Proposed RuleJun 29, 2026
Establishment Registration and Product Listing for Tobacco Products →DrugFood
Comments close Sep 14, 2026
RuleJun 29, 2026
Medical Devices; Orthopedic Devices; Classification of the Medial Knee Implanted Shock Absorber →DrugDeviceFood
RuleJun 26, 2026
Medical Devices; General Hospital and Personal Use Devices; Classification of the Infant Supine Sleep System →DrugDeviceFood
NoticeJun 26, 2026
Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability →DrugDeviceFoodCosmetics
NoticeJun 26, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; Time and Extent Applications for Nonprescription Drug Products →DrugDeviceFood
Closed Aug 25, 2026
RuleJun 26, 2026
Medical Devices; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test →DrugDeviceFood
RuleJun 26, 2026
Medical Devices; General and Plastic Surgery Devices; Classification of the Breast Implant Suction Retrieval System →DrugDeviceFood
NoticeJun 26, 2026
List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period →DrugFoodCosmetics
Closed May 1, 2026
NoticeJun 24, 2026
Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials; Draft Guidance for Industry; Availability →DrugBiologicsFood
Closed Jul 24, 2026
NoticeJun 24, 2026
Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Availability →DrugBiologicsFood
Closed Aug 24, 2026
NoticeJun 24, 2026
Expedited Investigational New Drug Pilot Program; Request for Information →DrugFood
Closed Jul 22, 2026
NoticeJun 24, 2026
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Revised Draft Guidance for Industry; Availability →DrugBiologicsFood
Comments close Sep 22, 2026
NoticeJun 23, 2026
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification of Identity, Form FDA 3975 →DrugFood
Closed Jul 23, 2026
NoticeJun 23, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; Potential Tobacco Product Violations Reporting Form →DrugDeviceFood
Closed Aug 24, 2026
RuleJun 22, 2026
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Light-Projecting Measuring Device →DrugDeviceFood
RuleJun 22, 2026
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Traction Device →DrugDeviceFood
NoticeJun 18, 2026
Advisory Committee; Science Board to the Food and Drug Administration; Renewal →DrugFood
NoticeJun 18, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals →DrugDeviceFood
Closed Aug 17, 2026
NoticeJun 18, 2026
Authorization of Emergency Use for Two Animal Drugs for the Prevention and Treatment of New World Screwworm; Availability →DrugFoodCosmeticsVeterinary
RuleJun 17, 2026
Medical Devices; Gastroenterology-Urology Devices; Classification of the Ingestible Gastrointestinal Blood Detection Capsule →DrugBiologicsDeviceFood
NoticeJun 15, 2026
Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability →DrugFood
Closed Aug 14, 2026
NoticeJun 11, 2026
Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments; Reopening of the Comment Period →DrugFood
Closed Jul 13, 2026
NoticeJun 11, 2026
Drug Repurposing for Unmet Medical Needs; Request for Information; Extension of Comment Period →DrugFood
Closed Jul 13, 2026
RuleJun 5, 2026
Medical Devices; Orthopedic Devices; Classification of the Absorbable Metallic Bone Fixation Fastener →DrugDeviceFood
NoticeJun 3, 2026
Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry; Availability →DrugBiologicsFood
Closed Sep 1, 2026
NoticeJun 3, 2026
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability →DrugDeviceFood
Closed Aug 3, 2026
NoticeJun 3, 2026
Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications →DrugFood
NoticeJun 3, 2026
Third Annual Animal Drug User Fee Educational Conference; Public Meeting →DrugFoodVeterinary
RuleJun 1, 2026
Medical Devices; Hematology and Pathology Devices; Classification of the Von Willebrand Factor Assay →DrugDeviceFood
NoticeJun 1, 2026
Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability →DrugBiologicsDeviceFood
Closed Jul 31, 2026
RuleJun 1, 2026
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Oropharyngeal Electrical Stimulator →DrugDeviceFood
RuleJun 1, 2026
Medical Devices; Dental Devices; Classification of the Intraoral Cooling Device →DrugDeviceFood
NoticeMay 29, 2026
Patient-Focused Drug Development for Nonhealing Chronic Wounds; Public Meeting; Request for Comments →DrugFood
Comments close Oct 26, 2026
NoticeMay 29, 2026
Statistical Approaches To Establishing Bioequivalence; Guidance for Industry; Availability →DrugDeviceFood
NoticeMay 29, 2026
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Guidance for Industry; Availability →DrugDeviceFoodCosmetics
NoticeMay 29, 2026
Advisory Committee; Psychopharmacologic Drugs Advisory Committee; Renewal →DrugFood
NoticeMay 28, 2026
AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information; Extension of Comment Period →DrugFood
Closed Jun 29, 2026
NoticeMay 28, 2026
Challenges and Solutions in Lot-Level Food Traceability; Public Meeting and Request for Comments →DrugFood
Closed Jul 15, 2026
NoticeMay 26, 2026
Advisory Committee; Drug Safety and Risk Management Advisory Committee; Renewal →DrugFood
NoticeMay 26, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act →DrugDeviceFoodCosmetics
Closed Jul 27, 2026
NoticeMay 22, 2026
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability →DrugDeviceFood
Closed Jul 21, 2026
NoticeMay 21, 2026
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Required Warnings for Cigarette Packages and Advertisements →DrugFood
Closed Jun 22, 2026
Closed Jun 22, 2026
NoticeMay 21, 2026
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience/Events With Approved New Animal Drugs →DrugFoodVeterinary
Closed Jun 22, 2026
NoticeMay 13, 2026
Biomarker Incubator: Urinary Kidney Safety Biomarkers; Request for Information →DrugFood
Closed Jul 13, 2026
NoticeMay 13, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting →DrugBiologicsDeviceFood
Closed Jul 13, 2026
NoticeMay 13, 2026
Modified Risk Tobacco Product Application: Renewal Applications for VLN® King and VLN® Menthol King, Cigarette Products Submitted by 22nd Century Group Inc. →DrugFood
Closed May 13, 2026
NoticeMay 13, 2026
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; The Real Cost Campaign Outcomes Evaluation Study: Cohort 3 →DrugFood
Closed Jun 12, 2026
Closed Jul 13, 2026
Closed Jul 13, 2026
Closed Jun 11, 2026
NoticeMay 11, 2026
Postapproval Pregnancy Safety Studies; Guidance for Industry; Availability →DrugBiologicsDeviceFood
NoticeMay 11, 2026
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications On Medical Devices and Radiation-Emitting Products →DrugDeviceFood
Closed Jun 10, 2026
NoticeMay 11, 2026
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; AVLAYAH (tividenofusp alfa-eknm) →DrugFoodCosmetics
NoticeMay 11, 2026
Pulmonary Tuberculosis: Developing Drugs for Treatment; Guidance for Industry; Availability →DrugFood
NoticeMay 7, 2026
Patient-Matched Guides for Orthopedic Implants; Guidance for Industry and Food and Drug Administration Staff; Availability →DrugDeviceFood
NoticeMay 6, 2026
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; OTARMENI (lunsotogene parvec-cwha) →DrugFoodCosmetics
Closed Jul 6, 2026
NoticeMay 4, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; National Youth Tobacco Survey →DrugDeviceFood
Closed Jul 6, 2026
NoticeMay 1, 2026
List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act →DrugFoodCosmetics
Closed Jun 30, 2026
NoticeMay 1, 2026
Medical Devices; Exemptions From Premarket Notification: Certain Class II Devices; Request for Comments →DrugDeviceFood
Closed Jun 30, 2026
NoticeMay 1, 2026
Impacts of Patient-Focused Drug Development Meetings; Establishment of a Public Docket; Request for Information and Comments →DrugFood
Closed Jun 30, 2026
NoticeMay 1, 2026
Obesity and Drug Dosing: Clinical Pharmacology Considerations; Request for Comments →DrugBiologicsDeviceFood
Closed Jun 30, 2026
NoticeApr 30, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Requirements for Nonclinical Laboratory Studies →DrugDeviceFood
Closed Jun 29, 2026
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