| Dec 29, 2025 | Notice | Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products; Notice of Meeting; Establishment | record → |
| Dec 29, 2025 | Notice | Over-the-Counter Monograph Drug User Fee Amendments-OTC Monograph Order Request Fee Rates for Fiscal Year 2026 | record → |
| Dec 29, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing | record → |
| Dec 29, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; ROMVIMZA | record → |
| Dec 29, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; ALHEMO | record → |
| Dec 29, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; ADZYNMA | record → |
| Dec 29, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; LEQEMBI | record → |
| Dec 29, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; OJEMDA | record → |
| Dec 29, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; ZELSUVMI | record → |
| Dec 29, 2025 | Notice | Egis Pharmaceuticals Limited, et.al.; Proposal To Withdraw Approval of Three Abbreviated New Drug Applications; Opportunity for a Hearing | record → |
| Dec 29, 2025 | Notice | Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triag | record → |
| Dec 29, 2025 | Notice | Authorization of Emergency Use for Two Animal Drugs for the Treatment of New World Screwworm; Availability | record → |
| Dec 23, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance of | record → |
| Dec 23, 2025 | Notice | Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosme | record → |
| Dec 19, 2025 | Notice | Processes and Practices Applicable to Bioresearch Monitoring Inspections; Guidance for Industry; Availability | record → |
| Dec 19, 2025 | Notice | Determination That EFFEXOR XR (Venlafaxine Hydrochloride) Extended-Release Capsule, 100 Milligrams, Was Not Withdrawn From Sale for Reasons | record → |
| Dec 19, 2025 | Notice | Issuance of Priority Review Voucher; Rare Pediatric Disease Product; FORZINITY (Elamipretide) | record → |
| Dec 19, 2025 | Notice | Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; KEYTRUDA QLEX (pembrolizumab and berahyaluronid | record → |
| Dec 19, 2025 | Rule | Medical Devices; Neurological Devices; Classification of the Electrical Tongue Nerve Stimulator To Treat Motor Deficits | record → |
| Dec 19, 2025 | Notice | Determination That DEXCHLORPHENIRAMINE MALEATE (Dexchlorpheniramine Maleate, Oral Syrup, 2 Milligrams/5 Milliliters) Was Not Withdrawn From | record → |
| Dec 19, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Required Warnings for Cigarette Packages and Advertisements | record → |
| Dec 19, 2025 | Notice | Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals | record → |
| Dec 18, 2025 | Notice | Questions and Answers Regarding Mandatory Cosmetics Recalls: Draft Guidance for Industry; Availability | record → |
| Dec 18, 2025 | Notice | Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration | record → |
| Dec 16, 2025 | Notice | Investigator Responsibilities-Safety Reporting for Investigational Drugs and Devices; Guidance for Investigators, Industry, and Institutiona | record → |
| Dec 16, 2025 | Notice | Sponsor Responsibilities-Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Bi | record → |
| Dec 12, 2025 | Notice | Biosimilar User Fee Act; Stakeholder Consultation Meetings on Biosimilar User Fee Act Reauthorization; Request for Notification of Stakehold | record → |
| Dec 12, 2025 | Notice | Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use | record → |
| Dec 12, 2025 | Notice | Determination That ZANTAC (Ranitidine Hydrochloride) Injection, Equivalent to 25 Milligrams Base/Milliliter, Has Not Been Withdrawn From Sal | record → |
| Dec 12, 2025 | Notice | Determination That LUNELLE (Estradiol Cypionate and Medroxyprogesterone Acetate) Injectable, 5 Milligrams/0.5 Milliliter and 25 Milligrams/0 | record → |
| Dec 12, 2025 | Notice | Determination That DEMEROL (Meperidine Hydrochloride) Tablet, 100 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reaso | record → |
| Dec 12, 2025 | Notice | Determination That BACTROBAN (Mupirocin) Nasal Ointment, 2%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | record → |
| Dec 12, 2025 | Notice | Pfizer Inc., U.S. Agent for King Pharmaceuticals LLC, et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications | record → |
| Dec 11, 2025 | Notice | Food and Drug Administration Expert Panel on Testosterone Replacement Therapy for Men; Request for Information | record → |
| Dec 10, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; FILSUVEZ | record → |
| Dec 10, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; GRAFAPEX | record → |
| Dec 10, 2025 | Notice | Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable | record → |
| Dec 09, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Standards Quality Act Requirements | record → |
| Dec 09, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Establishment, Maintenance, and Availability of Records; Add | record → |
| Dec 09, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Humanitar | record → |
| Dec 08, 2025 | Notice | Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot | record → |
| Dec 08, 2025 | Notice | Revocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability | record → |
| Dec 08, 2025 | Notice | Product-Specific Guidance on Estradiol; Draft Guidance for Industry; Availability | record → |
| Dec 05, 2025 | Notice | Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability | record → |
| Dec 04, 2025 | Rule | Medical Devices; Quality Management System Regulation Technical Amendments | record → |
| Dec 03, 2025 | Notice | QTc Information in Human Prescription Drug and Biological Product Labeling; Guidance for Industry; Availability | record → |
| Dec 03, 2025 | Notice | Monoclonal Antibodies: Streamlined Nonclinical Safety Studies; Draft Guidance for Industry; Availability | record → |
| Dec 02, 2025 | Notice | Increasing Access to Nonprescription Drugs; Request for Information | record → |
| Dec 01, 2025 | Notice | Medical Gases-Current Good Manufacturing Practice; Draft Guidance for Industry; Availability | record → |
| Dec 01, 2025 | Notice | FDA's Strategy Document on Innovative Manufacturing Technologies | record → |
| Dec 01, 2025 | Notice | Q3E Guideline for Extractables and Leachables; International Council for Harmonisation; Draft Guidance for Industry; Availability | record → |
| Nov 28, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Center for Devices and Rad | record → |
| Nov 28, 2025 | Proposed Rule | Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products; Withdrawal | record → |
| Nov 26, 2025 | Rule | Medical Devices; Gastroenterology-Urology Devices; Classification of the Anchored Esophageal Sheath | record → |
| Nov 26, 2025 | Rule | Medical Devices; Neurological Devices; Classification of Field Generator Positioning Device | record → |
| Nov 26, 2025 | Notice | Cross-Center Master Files: Where To Submit; Draft Guidance for Industry; Availability | record → |
| Nov 26, 2025 | Proposed Rule | Green Innovation GmbH; Filing of Food Additive Petition (Animal Use) | record → |
| Nov 25, 2025 | Proposed Rule | Immunology and Microbiology Devices; Reclassification of Nucleic Acid-Based Test Systems for Use With a Corresponding Approved Oncology Ther | record → |
| Nov 25, 2025 | Notice | Nicole Shelby Randall: Final Debarment Order | record → |
| Nov 24, 2025 | Notice | Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments | record → |
| Nov 24, 2025 | Notice | Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine; Public Workshop; Request for Comments | record → |
| Nov 24, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; ENVISION MAMMOGRAPHY PLATFORM | record → |
| Nov 24, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; ALTIUS DIRECT ELECTRICAL NERVE STIMULATION SYSTEM | record → |
| Nov 24, 2025 | Notice | Intercept Pharmaceuticals, Inc., et al.; Withdrawal of Approval of New Drug Application for OCALIVA (Obeticholic Acid) Tablets, 5 Milligrams | record → |
| Nov 24, 2025 | Notice | Tobacco Products Scientific Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments | record → |
| Nov 24, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emergency Use Authorizatio | record → |
| Nov 24, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 510(k) Third-Party Review | record → |
| Nov 24, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the F | record → |
| Nov 24, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Procedures | record → |
| Nov 21, 2025 | Notice | Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability | record → |
| Nov 21, 2025 | Notice | General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice-Establishment of Public Docke | record → |
| Nov 21, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Small Dispensers Assessmen | record → |
| Nov 20, 2025 | Notice | Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparat | record → |
| Nov 18, 2025 | Notice | Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments; Guidance for Industry, F | record → |
| Nov 17, 2025 | Notice | Quality Management System Information for Certain Premarket Submission Reviews; Draft Guidance for Industry and Food and Drug Administration | record → |
| Nov 17, 2025 | Notice | Menstrual Products-Performance Testing and Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Ava | record → |
| Nov 17, 2025 | Notice | Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers; Guidance for Industry; Availability | record → |
| Nov 17, 2025 | Notice | Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use; Guidance for | record → |
| Nov 04, 2025 | Notice | Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for | record → |
| Oct 16, 2025 | Notice | Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs With a New World Screwworm-Related Indication; Guidance for Ind | record → |
| Oct 03, 2025 | Notice | Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 39 New Drug Applications; Correction | record → |
| Oct 02, 2025 | Notice | Revocation of Emergency Use of a Biological Product; Availability | record → |
| Oct 02, 2025 | Notice | Revocation of Emergency Use of Three Biological Products; Availability | record → |
| Oct 02, 2025 | Notice | Pediatric Advisory Committee (PAC); Notice of Meeting; Establishment of a Public Docket; Request for Comments | record → |
| Oct 02, 2025 | Notice | Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability | record → |
| Oct 01, 2025 | Notice | Jason Oppenheimer: Final Debarment Order | record → |
| Oct 01, 2025 | Notice | Yong Sheng Jiao: Denial of Application for Termination of Debarment | record → |
| Oct 01, 2025 | Rule | Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue; Confirmation of Effective Date | record → |
| Sep 30, 2025 | Notice | E20 Adaptive Designs for Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; Availability | record → |
| Sep 29, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE | record → |
| Sep 29, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; TRICLIP | record → |
| Sep 29, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; MIPLYFFA | record → |
| Sep 29, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on E | record → |
| Sep 29, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; NIKTIMVO | record → |
| Sep 29, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mitigation Strategies To P | record → |
| Sep 29, 2025 | Notice | Determination That SEMPREX-D (Acrivastine and Pseudoephedrine Hydrochloride) Capsules, 8 Milligrams and 60 Milligrams, Was Not Withdrawn Fro | record → |
| Sep 29, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation of Third-Par | record → |
| Sep 26, 2025 | Rule | Revocation of Food Standards for 11 Products Not Currently Sold; Confirmation of Effective Date | record → |
| Sep 25, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Agreement for Shipment of | record → |
| Sep 25, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Harmful and Pote | record → |
| Sep 25, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Sanitary Transportation of | record → |
| Sep 25, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Prohibited From | record → |
| Sep 25, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Food Facil | record → |
| Sep 25, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Production, Storage, and T | record → |
| Sep 25, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices for Positron Emission T | record → |
| Sep 25, 2025 | Notice | Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals | record → |
| Sep 25, 2025 | Notice | Postapproval Methods To Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Draft Guidance for Industry; Availability | record → |
| Sep 25, 2025 | Notice | Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations; Draft Guidance for Industry; Availability | record → |
| Sep 25, 2025 | Notice | Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry; Availability | record → |
| Sep 25, 2025 | Rule | Prior Notice: Adding Requirement To Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe for Post-R | record → |
| Sep 24, 2025 | Notice | Elite Laboratories, Inc., et al.; Withdrawal of Approval of 72 Abbreviated New Drug Applications | record → |
| Sep 24, 2025 | Notice | Computer Software Assurance for Production and Quality System Software; Guidance for Industry and Food and Drug Administration Staff; Availa | record → |
| Sep 24, 2025 | Notice | ADUFA V Third-Party Assessment Report: Notice of Availability; Virtual Public Meeting; Request for Comments | record → |
| Sep 24, 2025 | Notice | Approval of Previously Withdrawn New Drug Application for WELLCOVORIN (Leucovorin Calcium) Tablets | record → |
| Sep 23, 2025 | Notice | Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency; Guidance for Industry and Food | record → |
| Sep 23, 2025 | Notice | Malaria: Developing Drugs for Treatment; Draft Guidance for Industry; Availability | record → |
| Sep 22, 2025 | Notice | Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development-Leveraging Rare Diseas | record → |
| Sep 19, 2025 | Notice | Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availa | record → |
| Sep 19, 2025 | Notice | Ultra-Processed Foods; Request for Information; Extension of Comment Period | record → |
| Sep 19, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request, Exemptions From Substantia | record → |
| Sep 19, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Meetings With Industry and | record → |
| Sep 19, 2025 | Notice | Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-South | record → |
| Sep 19, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Health Document Su | record → |
| Sep 19, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Consi | record → |
| Sep 19, 2025 | Notice | William Goldsmith: Final Debarment Order | record → |
| Sep 19, 2025 | Rule | New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Chang | record → |
| Sep 19, 2025 | Rule | Regulation Identification Number 0910-AJ05 Medical Devices; Laboratory Developed Tests; Implementation of Vacatur | record → |
| Sep 18, 2025 | Notice | Fee Rate for Using a Priority Review Voucher in Fiscal Year 2026 | record → |
| Sep 18, 2025 | Rule | Radiological Health Regulations; Technical Amendments | record → |
| Sep 18, 2025 | Rule | Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices | record → |
| Sep 17, 2025 | Notice | Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability | record → |
| Sep 17, 2025 | Notice | Erosive Esophagitis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability | record → |
| Sep 17, 2025 | Notice | Disseminated Coccidioidomycosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability | record → |
| Sep 17, 2025 | Proposed Rule | Proposal To Remove the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausages | record → |
| Sep 12, 2025 | Notice | Digital Health Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Generative Artificial Intellige | record → |
| Sep 12, 2025 | Notice | Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications; Guidance for Industry; Availability | record → |
| Sep 11, 2025 | Notice | Development of Non-Opioid Analgesics for Chronic Pain, Draft Guidance for Industry; Availability | record → |
| Sep 09, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Product Establishm | record → |
| Sep 09, 2025 | Notice | Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations; Guidance for Ind | record → |
| Sep 09, 2025 | Notice | Classification Categories for Certain Supplements Under Biosimilar User Fee Amendments III; Guidance for Industry; Availability | record → |
| Sep 09, 2025 | Notice | M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver; International Council for Harmonisation; | record → |
| Sep 09, 2025 | Notice | E6(R3) Good Clinical Practice; International Council for Harmonisation; Guidance for Industry; Availability | record → |
| Sep 05, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Manufactured Food Regulato | record → |
| Sep 04, 2025 | Notice | Bausch & Lomb Incorporated, et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications; Correction | record → |
| Sep 04, 2025 | Rule | Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 in Yogurt and Other Cultured Dairy Products Fermented | record → |
| Sep 03, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; FDA Food Safety and Nutrit | record → |
| Sep 03, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices; | record → |
| Sep 03, 2025 | Notice | General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Dock | record → |
| Sep 03, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Accessories | record → |
| Sep 03, 2025 | Proposed Rule | Biomin GmbH; Filing of Food Additive Petition (Animal Use) | record → |
| Sep 03, 2025 | Notice | Determination That NUTRACORT (Hydrocortisone) Topical Gel, 1%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | record → |
| Sep 03, 2025 | Rule | Secondary Direct Food Additives Permitted in Food for Human Consumption; Hydrogen Peroxide | record → |
| Aug 29, 2025 | Rule | Advisory Committee; Arthritis Advisory Committee; Termination; Removal From List of Standing Committees | record → |
| Aug 29, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Submissions of | record → |
| Aug 29, 2025 | Notice | Amylyx Pharmaceuticals, Inc.; Withdrawal of Approval of New Drug Application for RELYVRIO (Sodium Phenylbutyrate and Taurursodiol) for Suspe | record → |
| Aug 28, 2025 | Notice | Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement | record → |
| Aug 28, 2025 | Notice | Patient-Focused Drug Development: Workshop #2 To Discuss Methodologic and Other Challenges Related to Patient Experience Data; Public Worksh | record → |
| Aug 28, 2025 | Notice | Issuance of Priority Review Voucher; Rare Pediatric Disease Product; MODESYO (dordaviprone) | record → |
| Aug 26, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; IQIRVO | record → |
| Aug 26, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; LUMISIGHT | record → |
| Aug 26, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; NEMLUVIO | record → |
| Aug 26, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Generally Recog | record → |
| Aug 26, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; YORVIPATH | record → |
| Aug 26, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; ZUNVEYL | record → |
| Aug 26, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; VORANIGO | record → |
| Aug 26, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; OHTUVAYRE | record → |
| Aug 26, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; CAMZYOS | record → |
| Aug 26, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; PIASKY | record → |
| Aug 26, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; SOFDRA | record → |
| Aug 26, 2025 | Notice | Determination That Four Heparin Sodium In Sodium Chloride In Plastic Container (Heparin Sodium) Drug Products Were Not Withdrawn From Sale f | record → |
| Aug 25, 2025 | Notice | Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment; Public Meeting; Request for Comments | record → |
| Aug 22, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Food and Egg Regulatory Program Standards | record → |
| Aug 22, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Reagents for D | record → |
| Aug 22, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records | record → |
| Aug 22, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Restricting the Sale and Distribution of Cigaret | record → |
| Aug 22, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Retailer Training Programs | record → |
| Aug 22, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishing and Maintaini | record → |
| Aug 22, 2025 | Rule | New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Chang | record → |
| Aug 22, 2025 | Notice | Animal Studies for Dental Bone Grafting Material Devices-Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Dru | record → |
| Aug 21, 2025 | Notice | Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; | record → |
| Aug 21, 2025 | Rule | Medical Devices; Immunology and Microbiology Devices; Classification of the Device That Detects Nucleic Acid Sequences From Microorganisms A | record → |
| Aug 21, 2025 | Rule | Medical Devices; Immunology and Microbiology Devices; Classification of the Anti-Phospholipase A2 Receptor Immunological Test System | record → |
| Aug 21, 2025 | Rule | Medical Devices; Immunology and Microbiology Devices; Classification of the Postnatal Chromosomal Copy Number Variation Detection System | record → |
| Aug 21, 2025 | Rule | Medical Devices; Radiology Devices; Classification of the Liver Iron Concentration Imaging Companion Diagnostic for Deferasirox | record → |
| Aug 21, 2025 | Rule | Medical Devices; Immunology and Microbiology Devices; Classification of A Multiplex Respiratory Panel To Detect and Identify Emerging Respir | record → |
| Aug 21, 2025 | Rule | Medical Devices; Immunology and Microbiology Devices; Classification of the Cancer Predisposition Risk Assessment System | record → |
| Aug 21, 2025 | Rule | Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Menopause Test System | record → |
| Aug 21, 2025 | Rule | Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Pharmacogenetic Assessment System | record → |
| Aug 21, 2025 | Rule | Medical Devices; Immunology and Microbiology Devices; Classification of the Mutation Detection Test for Myeloproliferative Neoplasms | record → |
| Aug 21, 2025 | Rule | Medical Devices; Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use With Total Disc Replacement Device | record → |
| Aug 21, 2025 | Rule | Medical Devices; Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use With Non-Fusion Spinous Process Sp | record → |
| Aug 21, 2025 | Rule | Medical Devices; Gastroenterology-Urology Devices; Classification of the Laparoscopic Gastrointestinal Sizing Tool | record → |
| Aug 21, 2025 | Rule | Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract; Confirmation of Effective Date | record → |
| Aug 21, 2025 | Rule | Listing of Color Additives Exempt From Certification; Galdieria Extract Blue; Confirmation of Effective Date | record → |
| Aug 21, 2025 | Rule | Listing of Color Additives Exempt From Certification; Calcium Phosphate; Confirmation of Effective Date | record → |
| Aug 19, 2025 | Notice | Determination That RIFADIN (Rifampin) Capsules, 150 Milligrams and 300 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Eff | record → |
| Aug 19, 2025 | Notice | Doyal Kalita: Final Debarment Order | record → |
| Aug 19, 2025 | Proposed Rule | Evonik Corporation; Filing of Food Additive Petition (Animal Use) | record → |
| Aug 19, 2025 | Notice | Approaches to Assessment of Overall Survival in Oncology Clinical Trials; Draft Guidance for Industry; Availability | record → |
| Aug 19, 2025 | Notice | Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development; Draft Guidance for Industry; Availability | record → |
| Aug 19, 2025 | Notice | Lessons Learned From the Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Public Workshop; Request for Commen | record → |
| Aug 15, 2025 | Notice | Revocation of Authorization of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability | record → |
| Aug 15, 2025 | Notice | Biosimilar User Fee Act III Regulatory Science Program Interim Public Meeting; Public Meeting; Interim Report; Availability; Request for Com | record → |
| Aug 15, 2025 | Notice | Advancing the Development of Interchangeable Products: Identifying Future Needs; Public Workshop; Request for Comments | record → |
| Aug 14, 2025 | Proposed Rule | Food Standards of Identity Modernization; Pasteurized Orange Juice; Proposed Rule; Correction | record → |
| Aug 08, 2025 | Notice | Product-Specific Guidance on Iron Sucrose; Draft Guidance for Industry; Availability | record → |
| Aug 08, 2025 | Notice | Onshoring Manufacturing of Drugs and Biological Products; Public Meeting; Request for Comments | record → |
| Aug 07, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Humanitarian Use Devices | record → |
| Aug 07, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on Medical Devices and Radiation-Emit | record → |
| Aug 07, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Collection of Conflict-of-Interest Information for Participa | record → |
| Aug 07, 2025 | Proposed Rule | Requirements for Additional Traceability Records for Certain Foods: Compliance Date Extension | record → |
| Aug 06, 2025 | Rule | Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue; Correction | record → |
| Aug 06, 2025 | Proposed Rule | Food Standards of Identity Modernization; Pasteurized Orange Juice | record → |
| Aug 04, 2025 | Notice | Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction | record → |
| Aug 04, 2025 | Notice | Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 39 New Drug Applications | record → |
| Aug 04, 2025 | Notice | Prescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application | record → |
| Aug 04, 2025 | Notice | Determination That HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (Heparin Sodium) Injectable, 200 Units/100 Millil | record → |
| Aug 04, 2025 | Notice | Determination That ROXICET (Oxycodone Hydrochloride and Acetaminophen) Tablet, 5 Milligrams and 325 Milligrams, Was Not Withdrawn From Sale | record → |
| Jul 31, 2025 | Notice | Medical Device User Fee Small Business Qualification and Determination Guidance Final Guidance for Industry and Food and Drug Administration | record → |
| Jul 30, 2025 | Notice | Arthritis Advisory Committee; Termination | record → |
| Jul 30, 2025 | Notice | General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice-Establishment of Public Docket; Req | record → |
| Jul 30, 2025 | Notice | Tobacco Products Scientific Advisory Committee; Notice of Meeting | record → |
| Jul 30, 2025 | Notice | Food Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2026 | record → |
| Jul 30, 2025 | Notice | Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2026 | record → |
| Jul 30, 2025 | Notice | Outsourcing Facility Fee Rates for Fiscal Year 2026 | record → |
| Jul 30, 2025 | Notice | Generic Drug User Fee Rates for Fiscal Year 2026 | record → |
| Jul 30, 2025 | Notice | Medical Device User Fee Rates for Fiscal Year 2026 | record → |
| Jul 30, 2025 | Notice | Prescription Drug User Fee Rates for Fiscal Year 2026 | record → |
| Jul 30, 2025 | Notice | Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2026 | record → |
| Jul 30, 2025 | Notice | Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2026 | record → |
| Jul 30, 2025 | Notice | Biosimilar User Fee Rates for Fiscal Year 2026 | record → |
| Jul 30, 2025 | Notice | Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2026 | record → |
| Jul 29, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Products, User Fee | record → |
| Jul 29, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Notification Procedures fo | record → |
| Jul 29, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tropical Disease Priority | record → |
| Jul 29, 2025 | Notice | Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals | record → |
| Jul 29, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Compounding Animal Drugs F | record → |
| Jul 29, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Public Health Service Guid | record → |
| Jul 29, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Foreign Supplier Verificat | record → |
| Jul 29, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export Notification and Re | record → |
| Jul 29, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Reporting | record → |
| Jul 29, 2025 | Notice | Revocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability | record → |
| Jul 29, 2025 | Proposed Rule | APIX Biosciences US LLC; Filing of Food Additive Petition (Animal Use) | record → |
| Jul 29, 2025 | Proposed Rule | Spoonbill Foundation; Filing of Food Additive Petition | record → |
| Jul 28, 2025 | Rule | Regulatory Hearing Before the Food and Drug Administration | record → |
| Jul 25, 2025 | Notice | Ultra-Processed Foods; Request for Information | record → |
| Jul 21, 2025 | Notice | E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; | record → |
| Jul 21, 2025 | Notice | Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products; Guidance for Indust | record → |
| Jul 17, 2025 | Notice | Development of Cancer Drugs for Use in Novel Combination-Determining the Contribution of the Individual Drugs' Effects; Draft Guidance for I | record → |
| Jul 17, 2025 | Proposed Rule | Proposal To Revoke 23 Standards of Identity for Foods | record → |
| Jul 17, 2025 | Rule | Revocation of Food Standards for 11 Products Not Currently Sold | record → |
| Jul 17, 2025 | Proposed Rule | Revocation of Food Standards for 11 Products Not Currently Sold | record → |
| Jul 17, 2025 | Proposed Rule | Proposal To Revoke 18 Standards of Identity for Dairy Products | record → |
| Jul 16, 2025 | Notice | Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen; Draft Guidance for Industry; Availability | record → |
| Jul 15, 2025 | Rule | Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue | record → |
| Jul 14, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; IMDELLTRA | record → |
| Jul 14, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; KISUNLA | record → |
| Jul 14, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; ABRYSVO | record → |
| Jul 14, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; The Real Cost Campaign Outcomes Evaluation Study: Cohort 3 | record → |
| Jul 14, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; HEMGENIX | record → |
| Jul 14, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Emergency Use Authorization of Medical Products | record → |
| Jul 14, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Q-Submission and Early Payor Feedback Request Programs and M | record → |
| Jul 14, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Products | record → |
| Jul 14, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; LAZCLUZE | record → |
| Jul 14, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; TECELRA | record → |
| Jul 11, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Certification of Identity for Freedom of Information Act and | record → |
| Jul 11, 2025 | Notice | Request for Nominations for Voting Members on the Tobacco Products Scientific Advisory Committee | record → |
| Jul 09, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Meetings With Industry and Investigators on the Research and | record → |
| Jul 03, 2025 | Notice | Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations; Dr | record → |
| Jul 03, 2025 | Notice | Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals | record → |
| Jul 03, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Procedures for Clinical Laboratory Improvemen | record → |
| Jul 03, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Warning Plans for Certain Tobacco Products | record → |
| Jul 03, 2025 | Notice | Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals | record → |
| Jul 03, 2025 | Notice | Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals | record → |
| Jul 03, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; 510(k) Third-Party Review Program | record → |
| Jul 03, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Quick Turnaround Testing of Communicat | record → |
| Jul 03, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Emerging Drug Safety Technology Meeting Program | record → |
| Jul 03, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Center for Devices and Radiological Health Appeals Processes | record → |
| Jul 03, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; The Real Cost Monthly Impl | record → |
| Jul 03, 2025 | Notice | General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of Public Docket; Requ | record → |
| Jul 03, 2025 | Notice | Determination That SYNDROS (Dronabinol) Solution, 5 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectivenes | record → |
| Jul 02, 2025 | Notice | Myelodysplastic Syndromes: Developing Drug and Biological Products for Treatment; Draft Guidance for Industry; Availability | record → |
| Jul 02, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization | record → |
| Jul 02, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Environmental Impact Considerations | record → |
| Jul 02, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Mitigation Strategies To Protect Food Against Intentional Ad | record → |
| Jul 02, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; [TOTAL POSTERIOR SPINE SYSTEM (TOPS SYSTEM)] | record → |
| Jul 02, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; [CHOCOLATE TOUCH (PACLITAXEL DRUG COATED PTA BALLOON CATHETER)] | record → |
| Jul 02, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; WINREVAIR | record → |
| Jul 02, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; REBYOTA | record → |
| Jul 02, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; ELREXFIO; Correction | record → |
| Jul 02, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; LIVDELZI | record → |
| Jun 27, 2025 | Notice | Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Guidance for Industry and Food and Dru | record → |
| Jun 27, 2025 | Notice | Medical Device User Fee Amendments; Stakeholder Meetings on the Medical Device User Fee Amendments of Fiscal Years 2028 to 2032 Reauthorizat | record → |
| Jun 27, 2025 | Notice | Change in Federal Payment and Collection Options | record → |
| Jun 27, 2025 | Notice | Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases-Questions and Answers; Guida | record → |
| Jun 27, 2025 | Notice | June 27, 2025-Agency Information Collection Activities; Proposed Collection; Comment Request; Meetings With Industry and Investigators on th | record → |
| Jun 27, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Production, Storage, and Transportation of Shell Eggs (Preve | record → |
| Jun 27, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Exemptions From Substantial Equivalence Requirements for Tob | record → |
| Jun 27, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities | record → |
| Jun 27, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Health Document Submission | record → |
| Jun 27, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed; Anima | record → |
| Jun 27, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Sanitary Transportation of Human and Animal Food | record → |
| Jun 27, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Harmful and Potentially Harmful Constituents in To | record → |
| Jun 27, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Generally Recognized as Safe: Notifications and C | record → |
| Jun 27, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Establishing That a Tobacco Product | record → |
| Jun 27, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Accreditation of Third-Party Certification Bodies To Conduct | record → |
| Jun 26, 2025 | Notice | Conducting Remote Regulatory Assessments-Questions and Answers; Guidance for Industry; Availability | record → |
| Jun 26, 2025 | Notice | Generic Drug User Fees; Consultation Meetings on Reauthorization of Generic Drug User Fee Amendments for Fiscal Years 2028-2032; Request for | record → |
| Jun 26, 2025 | Rule | Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Lysosomal Storage Disorder Newborn Screening Test | record → |
| Jun 26, 2025 | Rule | Medical Devices; Radiology Devices; Classification of the Cream for X-Ray Attenuation | record → |
| Jun 26, 2025 | Notice | Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 064 | record → |
| Jun 26, 2025 | Rule | Medical Devices; Hematology and Pathology Devices; Classification of the Fluorescence In Situ Hybridization-Based Detection of Chromosomal A | record → |
| Jun 26, 2025 | Rule | Medical Devices; Immunology and Microbiology Devices; Classification of the Herpes Simplex Virus Nucleic Acid-Based Assay for Central Nervou | record → |
| Jun 26, 2025 | Rule | Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Muscular Dystrophy Newborn Screening Test | record → |
| Jun 26, 2025 | Notice | Unique Device Identifier Requirements for Combination Products; Draft Guidance for Industry and FDA Staff; Availability | record → |
| Jun 26, 2025 | Notice | Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment; Guidance for Industry; Availability | record → |
| Jun 26, 2025 | Notice | Revocation of Authorization of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability | record → |
| Jun 25, 2025 | Notice | Request for Nominations for Voting Members on the Tobacco Products Scientific Advisory Committee | record → |
| Jun 25, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; [EDWARDS SAPIEN 3 TRANSCATHETER PULMONARY VALVE] | record → |
| Jun 25, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; AGAMREE | record → |
| Jun 25, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; [EDWARDS SAPIEN 3 ULTRA RESILIA-PMA 140031 S-141] | record → |
| Jun 25, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; FILSPARI | record → |
| Jun 25, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administrati | record → |
| Jun 24, 2025 | Notice | Q1 Stability Testing of Drug Substances and Drug Products; International Council for Harmonisation; Draft Guidance for Industry; Availabilit | record → |
| Jun 20, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submissions of Medical Device Registration and Li | record → |
| Jun 20, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; TALVEY | record → |
| Jun 20, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; ZILBRYSQ | record → |
| Jun 20, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; QALSODY | record → |
| Jun 20, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; VELSIPITY | record → |
| Jun 20, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; ALTUVIIIO | record → |
| Jun 20, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; JOENJA | record → |
| Jun 20, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; EXEM FOAM | record → |
| Jun 20, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; TRUQAP | record → |
| Jun 20, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; COLUMVI | record → |
| Jun 20, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; BREYANZI | record → |
| Jun 20, 2025 | Notice | Post-Warning Letter Meetings Under Generic Drug User Fee Amendments; Guidance for Industry; Availability | record → |
| Jun 20, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Interstate Shellfish Deale | record → |
| Jun 18, 2025 | Notice | Modified Risk Tobacco Product Application: Applications for ZYN Products Submitted by Swedish Match U.S.A., Inc. | record → |
| Jun 18, 2025 | Rule | Medical Devices; Exemptions From Premarket Notification: Class II Devices; Clinical Electronic Thermometers | record → |
| Jun 18, 2025 | Notice | Yogurt Products Deviating From Standard of Identity; Temporary Permit for Market Testing | record → |
| Jun 18, 2025 | Notice | Cheese Products Deviating From Standard of Identity; Temporary Permit for Market Testing | record → |
| Jun 17, 2025 | Notice | Psychopharmacologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Supplemental New Dru | record → |
| Jun 16, 2025 | Notice | Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologic License Application ( | record → |
| Jun 16, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drug and Veteri | record → |
| Jun 16, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance of Medical Devices | record → |
| Jun 16, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Accessories | record → |
| Jun 16, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Abbreviated New Animal Drug Applications | record → |
| Jun 16, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Detention a | record → |
| Jun 16, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Medical Devices; Foreign Letters of Approval | record → |
| Jun 16, 2025 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Manufactured Food Regulatory Program Standards | record → |
| Jun 16, 2025 | Notice | Abbreviated New Drug Applications: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions; Guidance for Indu | record → |
| Jun 16, 2025 | Notice | Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population; Public Meeting; Establishmen | record → |
| Jun 16, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; BRIUMVI | record → |
| Jun 16, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; POMBILITI | record → |
| Jun 16, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; [IMPELLA RP FLEX WITH SMART ASSIST] | record → |
| Jun 16, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; [AVEIR VR LEADLESS SYSTEM] | record → |
| Jun 16, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; XOLREMDI | record → |
| Jun 16, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; VOYDEYA | record → |
| Jun 16, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; VAFSEO | record → |
| Jun 16, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; [NAVITOR TRANSCATHETER AORTIC VALVE IMPLANT] | record → |
| Jun 16, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; ZEVTERA | record → |
| Jun 16, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; VOWST | record → |
| Jun 16, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; RIVFLOZA | record → |
| Jun 16, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; ROLVEDON | record → |
| Jun 16, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; BEYFORTUS | record → |
| Jun 13, 2025 | Notice | Pediatric Advisory Committee (PAC); Notice of Meeting; Establishment of a Public Docket; Request for Comments | record → |
| Jun 13, 2025 | Notice | Request for Nominations for Individuals and Consumer Organizations for Advisory Committees | record → |
| Jun 13, 2025 | Rule | Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Fungal Nucleic Acids Directly in R | record → |
| Jun 13, 2025 | Rule | Medical Devices; Immunology and Microbiology Devices; Classification of the Cellular Analysis System for Multiplexed Antimicrobial Susceptib | record → |
| Jun 13, 2025 | Rule | Medical Devices; Immunology and Microbiology Devices; Classification of the Clinical Mass Spectrometry Microorganism Identification and Diff | record → |
| Jun 13, 2025 | Rule | Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Detection and Diagnosis Software | record → |
| Jun 13, 2025 | Notice | Rare Disease Innovation, Science, and Exploration Public Workshop Series; Request for Comments | record → |
| Jun 11, 2025 | Proposed Rule | Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Ther | record → |
| Jun 11, 2025 | Notice | Reauthorization of the Medical Device User Fee Amendments; Public Meeting; Request for Comments | record → |
| Jun 09, 2025 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Sm | record → |
| Jun 06, 2025 | Notice | Hernia Mesh-Package Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability | record → |
| Jun 06, 2025 | Notice | M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol; International Council for Harmonisation; Draft Technical Sp | record → |
| Jun 05, 2025 | Notice | Transfer of a Premarket Notification (510(k)) Clearance-Questions and Answers; Draft Guidance for Industry and Food and Drug Administration | record → |
| Jun 05, 2025 | Notice | Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for | record → |
| Jun 05, 2025 | Notice | Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph | record → |
| Jun 05, 2025 | Notice | Over-the-Counter Monograph Condition B001: Single-Unit or Unit-Dose Containers for Over-the-Counter Monograph Drugs in Orally Disintegrating | record → |
| Jun 05, 2025 | Notice | Raw Data for Safety and Effectiveness Studies; Guidance for Industry; Availability | record → |
| Jun 02, 2025 | Rule | Medical Devices; Radiology Devices; Classification of the Radiological Acquisition and/or Optimization Guidance System | record → |
| Jun 02, 2025 | Rule | Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect Bacterial Protease Activity in Chronic Wound Fl | record → |
| Jun 02, 2025 | Notice | M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver; International Council for Harmonisation; | record → |
| Jun 02, 2025 | Notice | Determination That EPINEPHRINE (Epinephrine) Solution, 1 Milligram/Milliliter, Prefilled Syringe for Intravenous Use, Was Not Withdrawn From | record → |
| May 30, 2025 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; LOQTORZI | record → |
| May 30, 2025 | Notice | Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability | record → |
| May 30, 2025 | Notice | Determination That COREG CR (Carvedilol Phosphate) Extended-Release Capsules, 10 Milligrams, 20 Milligrams, 40 Milligrams, and 80 Milligrams | record → |
| May 30, 2025 | Rule | Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Mullerian Hormone Test System | record → |
| May 30, 2025 | Notice | Determination That ACTIGALL (Ursodiol) Capsule, 150 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | record → |
| May 30, 2025 | Notice | Meda AB and B. Braun Medical, Inc.; Withdrawal of Approval of Two New Drug Applications | record → |
| May 30, 2025 | Notice | Evan Asher Field: Final Debarment Order | record → |
| May 30, 2025 | Notice | Replacing Color Additives in Approved or Marketed Drug Products; Draft Guidance for Industry; Availability | record → |
| May 29, 2025 | Notice | Second Annual Animal Drug User Fee Educational Conference; Public Meeting | record → |
| May 29, 2025 | Notice | Electronic Submission Template for Medical Device Q-Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availab | record → |
| May 29, 2025 | Notice | Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Guidance for Industry and Food and Drug Adminis | record → |
| May 29, 2025 | Rule | Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Plazomicin Test System | record → |
| May 29, 2025 | Rule | Medical Devices; Immunology and Microbiology Devices; Classification of the Zika Virus Serological Reagents | record → |
| May 29, 2025 | Rule | Medical Devices; Gastroenterology-Urology Devices; Classification of the Temporarily-Placed Urethral Opening System for Symptoms of Benign P | record → |