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federal register · 2025

How many rules and notices did Food and Drug Administration publish in 2025?

In 2025 Food and Drug Administration published 576 Federal Register documents: 74 final rules, 21 proposed rules, 481 notices; 5 marked significant. Busiest month: 2025-06.

DOCUMENTS: 576FINAL RULES: 74PROPOSED: 21

Cite: FACTANKER, https://factanker.com/federal-register/food-and-drug-administration/2025

What stands out

In 2025 Food and Drug Administration published 576 Federal Register documents: 74 final rules, 21 proposed rules, 481 notices; 5 marked significant. Busiest month: 2025-06.

By month

MonthDocumentsFinal rulesProposedNotices
2025-01666357
2025-024103
2025-03171115
2025-04200020
2025-058320261
2025-069512182
2025-07733565
2025-086618444
2025-09648254
2025-109108
2025-11282323
2025-12512049

Documents, 2025

The 400 most recent; the JSON view carries the same list.

PublishedTypeDocumentEvidence
Dec 29, 2025NoticeRoundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products; Notice of Meeting; Establishment record →
Dec 29, 2025NoticeOver-the-Counter Monograph Drug User Fee Amendments-OTC Monograph Order Request Fee Rates for Fiscal Year 2026record →
Dec 29, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturingrecord →
Dec 29, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ROMVIMZArecord →
Dec 29, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ALHEMOrecord →
Dec 29, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ADZYNMArecord →
Dec 29, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; LEQEMBIrecord →
Dec 29, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; OJEMDArecord →
Dec 29, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ZELSUVMIrecord →
Dec 29, 2025NoticeEgis Pharmaceuticals Limited, et.al.; Proposal To Withdraw Approval of Three Abbreviated New Drug Applications; Opportunity for a Hearingrecord →
Dec 29, 2025NoticeMedical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triagrecord →
Dec 29, 2025NoticeAuthorization of Emergency Use for Two Animal Drugs for the Treatment of New World Screwworm; Availabilityrecord →
Dec 23, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance ofrecord →
Dec 23, 2025NoticeFormal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmerecord →
Dec 19, 2025NoticeProcesses and Practices Applicable to Bioresearch Monitoring Inspections; Guidance for Industry; Availabilityrecord →
Dec 19, 2025NoticeDetermination That EFFEXOR XR (Venlafaxine Hydrochloride) Extended-Release Capsule, 100 Milligrams, Was Not Withdrawn From Sale for Reasons record →
Dec 19, 2025NoticeIssuance of Priority Review Voucher; Rare Pediatric Disease Product; FORZINITY (Elamipretide)record →
Dec 19, 2025NoticeNotice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; KEYTRUDA QLEX (pembrolizumab and berahyaluronidrecord →
Dec 19, 2025RuleMedical Devices; Neurological Devices; Classification of the Electrical Tongue Nerve Stimulator To Treat Motor Deficitsrecord →
Dec 19, 2025NoticeDetermination That DEXCHLORPHENIRAMINE MALEATE (Dexchlorpheniramine Maleate, Oral Syrup, 2 Milligrams/5 Milliliters) Was Not Withdrawn From record →
Dec 19, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Required Warnings for Cigarette Packages and Advertisementsrecord →
Dec 19, 2025NoticeAgency Information Collection Activities; Announcement of Office of Management and Budget Approvalsrecord →
Dec 18, 2025NoticeQuestions and Answers Regarding Mandatory Cosmetics Recalls: Draft Guidance for Industry; Availabilityrecord →
Dec 18, 2025NoticeUse of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administrationrecord →
Dec 16, 2025NoticeInvestigator Responsibilities-Safety Reporting for Investigational Drugs and Devices; Guidance for Investigators, Industry, and Institutionarecord →
Dec 16, 2025NoticeSponsor Responsibilities-Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Birecord →
Dec 12, 2025NoticeBiosimilar User Fee Act; Stakeholder Consultation Meetings on Biosimilar User Fee Act Reauthorization; Request for Notification of Stakeholdrecord →
Dec 12, 2025NoticeAmending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Userecord →
Dec 12, 2025NoticeDetermination That ZANTAC (Ranitidine Hydrochloride) Injection, Equivalent to 25 Milligrams Base/Milliliter, Has Not Been Withdrawn From Salrecord →
Dec 12, 2025NoticeDetermination That LUNELLE (Estradiol Cypionate and Medroxyprogesterone Acetate) Injectable, 5 Milligrams/0.5 Milliliter and 25 Milligrams/0record →
Dec 12, 2025NoticeDetermination That DEMEROL (Meperidine Hydrochloride) Tablet, 100 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasorecord →
Dec 12, 2025NoticeDetermination That BACTROBAN (Mupirocin) Nasal Ointment, 2%, Was Not Withdrawn From Sale for Reasons of Safety or Effectivenessrecord →
Dec 12, 2025NoticePfizer Inc., U.S. Agent for King Pharmaceuticals LLC, et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applicationsrecord →
Dec 11, 2025NoticeFood and Drug Administration Expert Panel on Testosterone Replacement Therapy for Men; Request for Informationrecord →
Dec 10, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; FILSUVEZrecord →
Dec 10, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; GRAFAPEXrecord →
Dec 10, 2025NoticePromotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeablerecord →
Dec 09, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Mammography Standards Quality Act Requirementsrecord →
Dec 09, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Establishment, Maintenance, and Availability of Records; Addrecord →
Dec 09, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Humanitarrecord →
Dec 08, 2025NoticeTechnology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilotrecord →
Dec 08, 2025NoticeRevocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availabilityrecord →
Dec 08, 2025NoticeProduct-Specific Guidance on Estradiol; Draft Guidance for Industry; Availabilityrecord →
Dec 05, 2025NoticeProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availabilityrecord →
Dec 04, 2025RuleMedical Devices; Quality Management System Regulation Technical Amendmentsrecord →
Dec 03, 2025NoticeQTc Information in Human Prescription Drug and Biological Product Labeling; Guidance for Industry; Availabilityrecord →
Dec 03, 2025NoticeMonoclonal Antibodies: Streamlined Nonclinical Safety Studies; Draft Guidance for Industry; Availabilityrecord →
Dec 02, 2025NoticeIncreasing Access to Nonprescription Drugs; Request for Informationrecord →
Dec 01, 2025NoticeMedical Gases-Current Good Manufacturing Practice; Draft Guidance for Industry; Availabilityrecord →
Dec 01, 2025NoticeFDA's Strategy Document on Innovative Manufacturing Technologiesrecord →
Dec 01, 2025NoticeQ3E Guideline for Extractables and Leachables; International Council for Harmonisation; Draft Guidance for Industry; Availabilityrecord →
Nov 28, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Center for Devices and Radrecord →
Nov 28, 2025Proposed RuleTesting Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products; Withdrawalrecord →
Nov 26, 2025RuleMedical Devices; Gastroenterology-Urology Devices; Classification of the Anchored Esophageal Sheathrecord →
Nov 26, 2025RuleMedical Devices; Neurological Devices; Classification of Field Generator Positioning Devicerecord →
Nov 26, 2025NoticeCross-Center Master Files: Where To Submit; Draft Guidance for Industry; Availabilityrecord →
Nov 26, 2025Proposed RuleGreen Innovation GmbH; Filing of Food Additive Petition (Animal Use)record →
Nov 25, 2025Proposed RuleImmunology and Microbiology Devices; Reclassification of Nucleic Acid-Based Test Systems for Use With a Corresponding Approved Oncology Therrecord →
Nov 25, 2025NoticeNicole Shelby Randall: Final Debarment Orderrecord →
Nov 24, 2025NoticeReauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Commentsrecord →
Nov 24, 2025NoticeImproving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine; Public Workshop; Request for Commentsrecord →
Nov 24, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ENVISION MAMMOGRAPHY PLATFORMrecord →
Nov 24, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ALTIUS DIRECT ELECTRICAL NERVE STIMULATION SYSTEMrecord →
Nov 24, 2025NoticeIntercept Pharmaceuticals, Inc., et al.; Withdrawal of Approval of New Drug Application for OCALIVA (Obeticholic Acid) Tablets, 5 Milligramsrecord →
Nov 24, 2025NoticeTobacco Products Scientific Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Commentsrecord →
Nov 24, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emergency Use Authorizatiorecord →
Nov 24, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 510(k) Third-Party Review record →
Nov 24, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Frecord →
Nov 24, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Procedures record →
Nov 21, 2025NoticeProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availabilityrecord →
Nov 21, 2025NoticeGeneral Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice-Establishment of Public Dockerecord →
Nov 21, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Small Dispensers Assessmenrecord →
Nov 20, 2025NoticeScientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparatrecord →
Nov 18, 2025NoticePatient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments; Guidance for Industry, Frecord →
Nov 17, 2025NoticeQuality Management System Information for Certain Premarket Submission Reviews; Draft Guidance for Industry and Food and Drug Administrationrecord →
Nov 17, 2025NoticeMenstrual Products-Performance Testing and Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Avarecord →
Nov 17, 2025NoticeExpanded Access to Investigational Drugs for Treatment Use: Questions and Answers; Guidance for Industry; Availabilityrecord →
Nov 17, 2025NoticeConsiderations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use; Guidance for record →
Nov 04, 2025NoticeCirculatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request forrecord →
Oct 16, 2025NoticeDual Labeling for Fully Approved and Conditionally Approved New Animal Drugs With a New World Screwworm-Related Indication; Guidance for Indrecord →
Oct 03, 2025NoticeTeva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 39 New Drug Applications; Correctionrecord →
Oct 02, 2025NoticeRevocation of Emergency Use of a Biological Product; Availabilityrecord →
Oct 02, 2025NoticeRevocation of Emergency Use of Three Biological Products; Availabilityrecord →
Oct 02, 2025NoticePediatric Advisory Committee (PAC); Notice of Meeting; Establishment of a Public Docket; Request for Commentsrecord →
Oct 02, 2025NoticeProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availabilityrecord →
Oct 01, 2025NoticeJason Oppenheimer: Final Debarment Orderrecord →
Oct 01, 2025NoticeYong Sheng Jiao: Denial of Application for Termination of Debarmentrecord →
Oct 01, 2025RuleListing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue; Confirmation of Effective Daterecord →
Sep 30, 2025NoticeE20 Adaptive Designs for Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; Availabilityrecord →
Sep 29, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICErecord →
Sep 29, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; TRICLIPrecord →
Sep 29, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; MIPLYFFArecord →
Sep 29, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Erecord →
Sep 29, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; NIKTIMVOrecord →
Sep 29, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mitigation Strategies To Precord →
Sep 29, 2025NoticeDetermination That SEMPREX-D (Acrivastine and Pseudoephedrine Hydrochloride) Capsules, 8 Milligrams and 60 Milligrams, Was Not Withdrawn Frorecord →
Sep 29, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation of Third-Parrecord →
Sep 26, 2025RuleRevocation of Food Standards for 11 Products Not Currently Sold; Confirmation of Effective Daterecord →
Sep 25, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Agreement for Shipment of record →
Sep 25, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Harmful and Poterecord →
Sep 25, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Sanitary Transportation ofrecord →
Sep 25, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Prohibited Fromrecord →
Sep 25, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Food Facilrecord →
Sep 25, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Production, Storage, and Trecord →
Sep 25, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices for Positron Emission Trecord →
Sep 25, 2025NoticeAgency Information Collection Activities; Announcement of Office of Management and Budget Approvalsrecord →
Sep 25, 2025NoticePostapproval Methods To Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Draft Guidance for Industry; Availabilityrecord →
Sep 25, 2025NoticeInnovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations; Draft Guidance for Industry; Availabilityrecord →
Sep 25, 2025NoticeExpedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry; Availabilityrecord →
Sep 25, 2025RulePrior Notice: Adding Requirement To Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe for Post-Rrecord →
Sep 24, 2025NoticeElite Laboratories, Inc., et al.; Withdrawal of Approval of 72 Abbreviated New Drug Applicationsrecord →
Sep 24, 2025NoticeComputer Software Assurance for Production and Quality System Software; Guidance for Industry and Food and Drug Administration Staff; Availarecord →
Sep 24, 2025NoticeADUFA V Third-Party Assessment Report: Notice of Availability; Virtual Public Meeting; Request for Commentsrecord →
Sep 24, 2025NoticeApproval of Previously Withdrawn New Drug Application for WELLCOVORIN (Leucovorin Calcium) Tabletsrecord →
Sep 23, 2025NoticeConsideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency; Guidance for Industry and Food record →
Sep 23, 2025NoticeMalaria: Developing Drugs for Treatment; Draft Guidance for Industry; Availabilityrecord →
Sep 22, 2025NoticeAdvancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development-Leveraging Rare Diseasrecord →
Sep 19, 2025NoticeSafety Labeling Changes-Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availarecord →
Sep 19, 2025NoticeUltra-Processed Foods; Request for Information; Extension of Comment Periodrecord →
Sep 19, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request, Exemptions From Substantiarecord →
Sep 19, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Meetings With Industry andrecord →
Sep 19, 2025NoticeVaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Southrecord →
Sep 19, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Health Document Surecord →
Sep 19, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Consirecord →
Sep 19, 2025NoticeWilliam Goldsmith: Final Debarment Orderrecord →
Sep 19, 2025RuleNew Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Changrecord →
Sep 19, 2025RuleRegulation Identification Number 0910-AJ05 Medical Devices; Laboratory Developed Tests; Implementation of Vacaturrecord →
Sep 18, 2025NoticeFee Rate for Using a Priority Review Voucher in Fiscal Year 2026record →
Sep 18, 2025RuleRadiological Health Regulations; Technical Amendmentsrecord →
Sep 18, 2025RuleMicrobiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devicesrecord →
Sep 17, 2025NoticeSymptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availabilityrecord →
Sep 17, 2025NoticeErosive Esophagitis: Developing Drugs for Treatment; Draft Guidance for Industry; Availabilityrecord →
Sep 17, 2025NoticeDisseminated Coccidioidomycosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availabilityrecord →
Sep 17, 2025Proposed RuleProposal To Remove the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausagesrecord →
Sep 12, 2025NoticeDigital Health Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Generative Artificial Intelligerecord →
Sep 12, 2025NoticeAlternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications; Guidance for Industry; Availabilityrecord →
Sep 11, 2025NoticeDevelopment of Non-Opioid Analgesics for Chronic Pain, Draft Guidance for Industry; Availabilityrecord →
Sep 09, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Product Establishmrecord →
Sep 09, 2025NoticeDevelopment of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations; Guidance for Indrecord →
Sep 09, 2025NoticeClassification Categories for Certain Supplements Under Biosimilar User Fee Amendments III; Guidance for Industry; Availabilityrecord →
Sep 09, 2025NoticeM13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver; International Council for Harmonisation; record →
Sep 09, 2025NoticeE6(R3) Good Clinical Practice; International Council for Harmonisation; Guidance for Industry; Availabilityrecord →
Sep 05, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Manufactured Food Regulatorecord →
Sep 04, 2025NoticeBausch & Lomb Incorporated, et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications; Correctionrecord →
Sep 04, 2025RuleFood Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 in Yogurt and Other Cultured Dairy Products Fermentedrecord →
Sep 03, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; FDA Food Safety and Nutritrecord →
Sep 03, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices;record →
Sep 03, 2025NoticeGeneral Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Dockrecord →
Sep 03, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Accessoriesrecord →
Sep 03, 2025Proposed RuleBiomin GmbH; Filing of Food Additive Petition (Animal Use)record →
Sep 03, 2025NoticeDetermination That NUTRACORT (Hydrocortisone) Topical Gel, 1%, Was Not Withdrawn From Sale for Reasons of Safety or Effectivenessrecord →
Sep 03, 2025RuleSecondary Direct Food Additives Permitted in Food for Human Consumption; Hydrogen Peroxiderecord →
Aug 29, 2025RuleAdvisory Committee; Arthritis Advisory Committee; Termination; Removal From List of Standing Committeesrecord →
Aug 29, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Submissions of record →
Aug 29, 2025NoticeAmylyx Pharmaceuticals, Inc.; Withdrawal of Approval of New Drug Application for RELYVRIO (Sodium Phenylbutyrate and Taurursodiol) for Susperecord →
Aug 28, 2025NoticeChemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcementrecord →
Aug 28, 2025NoticePatient-Focused Drug Development: Workshop #2 To Discuss Methodologic and Other Challenges Related to Patient Experience Data; Public Workshrecord →
Aug 28, 2025NoticeIssuance of Priority Review Voucher; Rare Pediatric Disease Product; MODESYO (dordaviprone)record →
Aug 26, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; IQIRVOrecord →
Aug 26, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; LUMISIGHTrecord →
Aug 26, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; NEMLUVIOrecord →
Aug 26, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Generally Recogrecord →
Aug 26, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; YORVIPATHrecord →
Aug 26, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ZUNVEYLrecord →
Aug 26, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; VORANIGOrecord →
Aug 26, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; OHTUVAYRErecord →
Aug 26, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; CAMZYOSrecord →
Aug 26, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; PIASKYrecord →
Aug 26, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; SOFDRArecord →
Aug 26, 2025NoticeDetermination That Four Heparin Sodium In Sodium Chloride In Plastic Container (Heparin Sodium) Drug Products Were Not Withdrawn From Sale frecord →
Aug 25, 2025NoticePrescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment; Public Meeting; Request for Commentsrecord →
Aug 22, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Animal Food and Egg Regulatory Program Standardsrecord →
Aug 22, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Reagents for Drecord →
Aug 22, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Recordsrecord →
Aug 22, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Regulations Restricting the Sale and Distribution of Cigaretrecord →
Aug 22, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Retailer Training Programsrecord →
Aug 22, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishing and Maintainirecord →
Aug 22, 2025RuleNew Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Changrecord →
Aug 22, 2025NoticeAnimal Studies for Dental Bone Grafting Material Devices-Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drurecord →
Aug 21, 2025NoticeFinancial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; record →
Aug 21, 2025RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Device That Detects Nucleic Acid Sequences From Microorganisms Arecord →
Aug 21, 2025RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Anti-Phospholipase A2 Receptor Immunological Test Systemrecord →
Aug 21, 2025RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Postnatal Chromosomal Copy Number Variation Detection Systemrecord →
Aug 21, 2025RuleMedical Devices; Radiology Devices; Classification of the Liver Iron Concentration Imaging Companion Diagnostic for Deferasiroxrecord →
Aug 21, 2025RuleMedical Devices; Immunology and Microbiology Devices; Classification of A Multiplex Respiratory Panel To Detect and Identify Emerging Respirrecord →
Aug 21, 2025RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Cancer Predisposition Risk Assessment Systemrecord →
Aug 21, 2025RuleMedical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Menopause Test Systemrecord →
Aug 21, 2025RuleMedical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Pharmacogenetic Assessment Systemrecord →
Aug 21, 2025RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Mutation Detection Test for Myeloproliferative Neoplasmsrecord →
Aug 21, 2025RuleMedical Devices; Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use With Total Disc Replacement Devicerecord →
Aug 21, 2025RuleMedical Devices; Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use With Non-Fusion Spinous Process Sprecord →
Aug 21, 2025RuleMedical Devices; Gastroenterology-Urology Devices; Classification of the Laparoscopic Gastrointestinal Sizing Toolrecord →
Aug 21, 2025RuleListing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract; Confirmation of Effective Daterecord →
Aug 21, 2025RuleListing of Color Additives Exempt From Certification; Galdieria Extract Blue; Confirmation of Effective Daterecord →
Aug 21, 2025RuleListing of Color Additives Exempt From Certification; Calcium Phosphate; Confirmation of Effective Daterecord →
Aug 19, 2025NoticeDetermination That RIFADIN (Rifampin) Capsules, 150 Milligrams and 300 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effrecord →
Aug 19, 2025NoticeDoyal Kalita: Final Debarment Orderrecord →
Aug 19, 2025Proposed RuleEvonik Corporation; Filing of Food Additive Petition (Animal Use)record →
Aug 19, 2025NoticeApproaches to Assessment of Overall Survival in Oncology Clinical Trials; Draft Guidance for Industry; Availabilityrecord →
Aug 19, 2025NoticeOncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development; Draft Guidance for Industry; Availabilityrecord →
Aug 19, 2025NoticeLessons Learned From the Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Public Workshop; Request for Commenrecord →
Aug 15, 2025NoticeRevocation of Authorization of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availabilityrecord →
Aug 15, 2025NoticeBiosimilar User Fee Act III Regulatory Science Program Interim Public Meeting; Public Meeting; Interim Report; Availability; Request for Comrecord →
Aug 15, 2025NoticeAdvancing the Development of Interchangeable Products: Identifying Future Needs; Public Workshop; Request for Commentsrecord →
Aug 14, 2025Proposed RuleFood Standards of Identity Modernization; Pasteurized Orange Juice; Proposed Rule; Correctionrecord →
Aug 08, 2025NoticeProduct-Specific Guidance on Iron Sucrose; Draft Guidance for Industry; Availabilityrecord →
Aug 08, 2025NoticeOnshoring Manufacturing of Drugs and Biological Products; Public Meeting; Request for Commentsrecord →
Aug 07, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Humanitarian Use Devicesrecord →
Aug 07, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on Medical Devices and Radiation-Emitrecord →
Aug 07, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Collection of Conflict-of-Interest Information for Participarecord →
Aug 07, 2025Proposed RuleRequirements for Additional Traceability Records for Certain Foods: Compliance Date Extensionrecord →
Aug 06, 2025RuleListing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue; Correctionrecord →
Aug 06, 2025Proposed RuleFood Standards of Identity Modernization; Pasteurized Orange Juicerecord →
Aug 04, 2025NoticeTeva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correctionrecord →
Aug 04, 2025NoticeTeva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 39 New Drug Applicationsrecord →
Aug 04, 2025NoticePrescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application record →
Aug 04, 2025NoticeDetermination That HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (Heparin Sodium) Injectable, 200 Units/100 Millilrecord →
Aug 04, 2025NoticeDetermination That ROXICET (Oxycodone Hydrochloride and Acetaminophen) Tablet, 5 Milligrams and 325 Milligrams, Was Not Withdrawn From Sale record →
Jul 31, 2025NoticeMedical Device User Fee Small Business Qualification and Determination Guidance Final Guidance for Industry and Food and Drug Administrationrecord →
Jul 30, 2025NoticeArthritis Advisory Committee; Terminationrecord →
Jul 30, 2025NoticeGeneral and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice-Establishment of Public Docket; Reqrecord →
Jul 30, 2025NoticeTobacco Products Scientific Advisory Committee; Notice of Meetingrecord →
Jul 30, 2025NoticeFood Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2026record →
Jul 30, 2025NoticeAnimal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2026record →
Jul 30, 2025NoticeOutsourcing Facility Fee Rates for Fiscal Year 2026record →
Jul 30, 2025NoticeGeneric Drug User Fee Rates for Fiscal Year 2026record →
Jul 30, 2025NoticeMedical Device User Fee Rates for Fiscal Year 2026record →
Jul 30, 2025NoticePrescription Drug User Fee Rates for Fiscal Year 2026record →
Jul 30, 2025NoticeFood Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2026record →
Jul 30, 2025NoticeFood Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2026record →
Jul 30, 2025NoticeBiosimilar User Fee Rates for Fiscal Year 2026record →
Jul 30, 2025NoticeAnimal Drug User Fee Rates and Payment Procedures for Fiscal Year 2026record →
Jul 29, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Products, User Feerecord →
Jul 29, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Notification Procedures forecord →
Jul 29, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tropical Disease Priority record →
Jul 29, 2025NoticeAgency Information Collection Activities; Announcement of Office of Management and Budget Approvalsrecord →
Jul 29, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Compounding Animal Drugs Frecord →
Jul 29, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Public Health Service Guidrecord →
Jul 29, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Foreign Supplier Verificatrecord →
Jul 29, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export Notification and Rerecord →
Jul 29, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Reportingrecord →
Jul 29, 2025NoticeRevocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availabilityrecord →
Jul 29, 2025Proposed RuleAPIX Biosciences US LLC; Filing of Food Additive Petition (Animal Use)record →
Jul 29, 2025Proposed RuleSpoonbill Foundation; Filing of Food Additive Petitionrecord →
Jul 28, 2025RuleRegulatory Hearing Before the Food and Drug Administrationrecord →
Jul 25, 2025NoticeUltra-Processed Foods; Request for Informationrecord →
Jul 21, 2025NoticeE21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; record →
Jul 21, 2025NoticeFormal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products; Guidance for Industrecord →
Jul 17, 2025NoticeDevelopment of Cancer Drugs for Use in Novel Combination-Determining the Contribution of the Individual Drugs' Effects; Draft Guidance for Irecord →
Jul 17, 2025Proposed RuleProposal To Revoke 23 Standards of Identity for Foodsrecord →
Jul 17, 2025RuleRevocation of Food Standards for 11 Products Not Currently Soldrecord →
Jul 17, 2025Proposed RuleRevocation of Food Standards for 11 Products Not Currently Soldrecord →
Jul 17, 2025Proposed RuleProposal To Revoke 18 Standards of Identity for Dairy Productsrecord →
Jul 16, 2025NoticeRecommendations for Testing Blood Donations for Hepatitis B Surface Antigen; Draft Guidance for Industry; Availabilityrecord →
Jul 15, 2025RuleListing of Color Additives Exempt From Certification; Gardenia (Genipin) Bluerecord →
Jul 14, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; IMDELLTRArecord →
Jul 14, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; KISUNLArecord →
Jul 14, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ABRYSVOrecord →
Jul 14, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; The Real Cost Campaign Outcomes Evaluation Study: Cohort 3record →
Jul 14, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; HEMGENIXrecord →
Jul 14, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Emergency Use Authorization of Medical Productsrecord →
Jul 14, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Q-Submission and Early Payor Feedback Request Programs and Mrecord →
Jul 14, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Electronic Productsrecord →
Jul 14, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; LAZCLUZErecord →
Jul 14, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; TECELRArecord →
Jul 11, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Certification of Identity for Freedom of Information Act andrecord →
Jul 11, 2025NoticeRequest for Nominations for Voting Members on the Tobacco Products Scientific Advisory Committeerecord →
Jul 09, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Meetings With Industry and Investigators on the Research andrecord →
Jul 03, 2025NoticeSmall Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations; Drrecord →
Jul 03, 2025NoticeAgency Information Collection Activities; Announcement of Office of Management and Budget Approvalsrecord →
Jul 03, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Administrative Procedures for Clinical Laboratory Improvemenrecord →
Jul 03, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Warning Plans for Certain Tobacco Productsrecord →
Jul 03, 2025NoticeAgency Information Collection Activities; Announcement of Office of Management and Budget Approvalsrecord →
Jul 03, 2025NoticeAgency Information Collection Activities; Announcement of Office of Management and Budget Approvalsrecord →
Jul 03, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; 510(k) Third-Party Review Programrecord →
Jul 03, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Quick Turnaround Testing of Communicatrecord →
Jul 03, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Emerging Drug Safety Technology Meeting Programrecord →
Jul 03, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Center for Devices and Radiological Health Appeals Processesrecord →
Jul 03, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; The Real Cost Monthly Implrecord →
Jul 03, 2025NoticeGeneral and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of Public Docket; Requrecord →
Jul 03, 2025NoticeDetermination That SYNDROS (Dronabinol) Solution, 5 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectivenesrecord →
Jul 02, 2025NoticeMyelodysplastic Syndromes: Developing Drug and Biological Products for Treatment; Draft Guidance for Industry; Availabilityrecord →
Jul 02, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilizationrecord →
Jul 02, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Environmental Impact Considerationsrecord →
Jul 02, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Mitigation Strategies To Protect Food Against Intentional Adrecord →
Jul 02, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; [TOTAL POSTERIOR SPINE SYSTEM (TOPS SYSTEM)]record →
Jul 02, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; [CHOCOLATE TOUCH (PACLITAXEL DRUG COATED PTA BALLOON CATHETER)]record →
Jul 02, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; WINREVAIRrecord →
Jul 02, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; REBYOTArecord →
Jul 02, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ELREXFIO; Correctionrecord →
Jul 02, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; LIVDELZIrecord →
Jun 27, 2025NoticeCybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Guidance for Industry and Food and Drurecord →
Jun 27, 2025NoticeMedical Device User Fee Amendments; Stakeholder Meetings on the Medical Device User Fee Amendments of Fiscal Years 2028 to 2032 Reauthorizatrecord →
Jun 27, 2025NoticeChange in Federal Payment and Collection Optionsrecord →
Jun 27, 2025NoticeAntibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases-Questions and Answers; Guidarecord →
Jun 27, 2025NoticeJune 27, 2025-Agency Information Collection Activities; Proposed Collection; Comment Request; Meetings With Industry and Investigators on threcord →
Jun 27, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Production, Storage, and Transportation of Shell Eggs (Preverecord →
Jun 27, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Exemptions From Substantial Equivalence Requirements for Tobrecord →
Jun 27, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilitiesrecord →
Jun 27, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Health Document Submissionrecord →
Jun 27, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed; Animarecord →
Jun 27, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Sanitary Transportation of Human and Animal Foodrecord →
Jun 27, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Reporting Harmful and Potentially Harmful Constituents in Torecord →
Jun 27, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Substances Generally Recognized as Safe: Notifications and Crecord →
Jun 27, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Establishing That a Tobacco Productrecord →
Jun 27, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Accreditation of Third-Party Certification Bodies To Conductrecord →
Jun 26, 2025NoticeConducting Remote Regulatory Assessments-Questions and Answers; Guidance for Industry; Availabilityrecord →
Jun 26, 2025NoticeGeneric Drug User Fees; Consultation Meetings on Reauthorization of Generic Drug User Fee Amendments for Fiscal Years 2028-2032; Request forrecord →
Jun 26, 2025RuleMedical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Lysosomal Storage Disorder Newborn Screening Testrecord →
Jun 26, 2025RuleMedical Devices; Radiology Devices; Classification of the Cream for X-Ray Attenuationrecord →
Jun 26, 2025NoticeFood and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 064record →
Jun 26, 2025RuleMedical Devices; Hematology and Pathology Devices; Classification of the Fluorescence In Situ Hybridization-Based Detection of Chromosomal Arecord →
Jun 26, 2025RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Herpes Simplex Virus Nucleic Acid-Based Assay for Central Nervourecord →
Jun 26, 2025RuleMedical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Muscular Dystrophy Newborn Screening Testrecord →
Jun 26, 2025NoticeUnique Device Identifier Requirements for Combination Products; Draft Guidance for Industry and FDA Staff; Availabilityrecord →
Jun 26, 2025NoticeEarly Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment; Guidance for Industry; Availabilityrecord →
Jun 26, 2025NoticeRevocation of Authorization of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availabilityrecord →
Jun 25, 2025NoticeRequest for Nominations for Voting Members on the Tobacco Products Scientific Advisory Committeerecord →
Jun 25, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; [EDWARDS SAPIEN 3 TRANSCATHETER PULMONARY VALVE]record →
Jun 25, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; AGAMREErecord →
Jun 25, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; [EDWARDS SAPIEN 3 ULTRA RESILIA-PMA 140031 S-141]record →
Jun 25, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; FILSPARIrecord →
Jun 25, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administratirecord →
Jun 24, 2025NoticeQ1 Stability Testing of Drug Substances and Drug Products; International Council for Harmonisation; Draft Guidance for Industry; Availabilitrecord →
Jun 20, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submissions of Medical Device Registration and Lirecord →
Jun 20, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; TALVEYrecord →
Jun 20, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ZILBRYSQrecord →
Jun 20, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; QALSODYrecord →
Jun 20, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; VELSIPITYrecord →
Jun 20, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ALTUVIIIOrecord →
Jun 20, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; JOENJArecord →
Jun 20, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; EXEM FOAMrecord →
Jun 20, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; TRUQAPrecord →
Jun 20, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; COLUMVIrecord →
Jun 20, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; BREYANZIrecord →
Jun 20, 2025NoticePost-Warning Letter Meetings Under Generic Drug User Fee Amendments; Guidance for Industry; Availabilityrecord →
Jun 20, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Interstate Shellfish Dealerecord →
Jun 18, 2025NoticeModified Risk Tobacco Product Application: Applications for ZYN Products Submitted by Swedish Match U.S.A., Inc.record →
Jun 18, 2025RuleMedical Devices; Exemptions From Premarket Notification: Class II Devices; Clinical Electronic Thermometersrecord →
Jun 18, 2025NoticeYogurt Products Deviating From Standard of Identity; Temporary Permit for Market Testingrecord →
Jun 18, 2025NoticeCheese Products Deviating From Standard of Identity; Temporary Permit for Market Testingrecord →
Jun 17, 2025NoticePsychopharmacologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Supplemental New Drurecord →
Jun 16, 2025NoticeOncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologic License Application (record →
Jun 16, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drug and Veterirecord →
Jun 16, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance of Medical Devicesrecord →
Jun 16, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Accessoriesrecord →
Jun 16, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Abbreviated New Animal Drug Applicationsrecord →
Jun 16, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Detention arecord →
Jun 16, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Export of Medical Devices; Foreign Letters of Approvalrecord →
Jun 16, 2025NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Manufactured Food Regulatory Program Standardsrecord →
Jun 16, 2025NoticeAbbreviated New Drug Applications: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions; Guidance for Indurecord →
Jun 16, 2025NoticeUse of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population; Public Meeting; Establishmenrecord →
Jun 16, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; BRIUMVIrecord →
Jun 16, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; POMBILITIrecord →
Jun 16, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; [IMPELLA RP FLEX WITH SMART ASSIST]record →
Jun 16, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; [AVEIR VR LEADLESS SYSTEM]record →
Jun 16, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; XOLREMDIrecord →
Jun 16, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; VOYDEYArecord →
Jun 16, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; VAFSEOrecord →
Jun 16, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; [NAVITOR TRANSCATHETER AORTIC VALVE IMPLANT]record →
Jun 16, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ZEVTERArecord →
Jun 16, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; VOWSTrecord →
Jun 16, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; RIVFLOZArecord →
Jun 16, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ROLVEDONrecord →
Jun 16, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; BEYFORTUSrecord →
Jun 13, 2025NoticePediatric Advisory Committee (PAC); Notice of Meeting; Establishment of a Public Docket; Request for Commentsrecord →
Jun 13, 2025NoticeRequest for Nominations for Individuals and Consumer Organizations for Advisory Committeesrecord →
Jun 13, 2025RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Fungal Nucleic Acids Directly in Rrecord →
Jun 13, 2025RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Cellular Analysis System for Multiplexed Antimicrobial Susceptibrecord →
Jun 13, 2025RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Clinical Mass Spectrometry Microorganism Identification and Diffrecord →
Jun 13, 2025RuleMedical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Detection and Diagnosis Softwarerecord →
Jun 13, 2025NoticeRare Disease Innovation, Science, and Exploration Public Workshop Series; Request for Commentsrecord →
Jun 11, 2025Proposed RuleHematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therrecord →
Jun 11, 2025NoticeReauthorization of the Medical Device User Fee Amendments; Public Meeting; Request for Commentsrecord →
Jun 09, 2025NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Smrecord →
Jun 06, 2025NoticeHernia Mesh-Package Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availabilityrecord →
Jun 06, 2025NoticeM11 Technical Specification: Clinical Electronic Structured Harmonised Protocol; International Council for Harmonisation; Draft Technical Sprecord →
Jun 05, 2025NoticeTransfer of a Premarket Notification (510(k)) Clearance-Questions and Answers; Draft Guidance for Industry and Food and Drug Administration record →
Jun 05, 2025NoticeRecommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms forrecord →
Jun 05, 2025NoticeOver-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monographrecord →
Jun 05, 2025NoticeOver-the-Counter Monograph Condition B001: Single-Unit or Unit-Dose Containers for Over-the-Counter Monograph Drugs in Orally Disintegratingrecord →
Jun 05, 2025NoticeRaw Data for Safety and Effectiveness Studies; Guidance for Industry; Availabilityrecord →
Jun 02, 2025RuleMedical Devices; Radiology Devices; Classification of the Radiological Acquisition and/or Optimization Guidance Systemrecord →
Jun 02, 2025RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect Bacterial Protease Activity in Chronic Wound Flrecord →
Jun 02, 2025NoticeM13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver; International Council for Harmonisation; record →
Jun 02, 2025NoticeDetermination That EPINEPHRINE (Epinephrine) Solution, 1 Milligram/Milliliter, Prefilled Syringe for Intravenous Use, Was Not Withdrawn Fromrecord →
May 30, 2025NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; LOQTORZIrecord →
May 30, 2025NoticeReport on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availabilityrecord →
May 30, 2025NoticeDetermination That COREG CR (Carvedilol Phosphate) Extended-Release Capsules, 10 Milligrams, 20 Milligrams, 40 Milligrams, and 80 Milligramsrecord →
May 30, 2025RuleMedical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Mullerian Hormone Test Systemrecord →
May 30, 2025NoticeDetermination That ACTIGALL (Ursodiol) Capsule, 150 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectivenessrecord →
May 30, 2025NoticeMeda AB and B. Braun Medical, Inc.; Withdrawal of Approval of Two New Drug Applicationsrecord →
May 30, 2025NoticeEvan Asher Field: Final Debarment Orderrecord →
May 30, 2025NoticeReplacing Color Additives in Approved or Marketed Drug Products; Draft Guidance for Industry; Availabilityrecord →
May 29, 2025NoticeSecond Annual Animal Drug User Fee Educational Conference; Public Meetingrecord →
May 29, 2025NoticeElectronic Submission Template for Medical Device Q-Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availabrecord →
May 29, 2025NoticeRequests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Guidance for Industry and Food and Drug Adminisrecord →
May 29, 2025RuleMedical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Plazomicin Test Systemrecord →
May 29, 2025RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Zika Virus Serological Reagentsrecord →
May 29, 2025RuleMedical Devices; Gastroenterology-Urology Devices; Classification of the Temporarily-Placed Urethral Opening System for Symptoms of Benign Precord →

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