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federal register · 2026

How many rules and notices did Food and Drug Administration publish in 2026?

In 2026 Food and Drug Administration published 591 Federal Register documents: 95 final rules, 29 proposed rules, 467 notices; 4 marked significant. Busiest month: 2026-06.

DOCUMENTS: 591FINAL RULES: 95PROPOSED: 29

Cite: FACTANKER, https://factanker.com/federal-register/food-and-drug-administration/2026

What stands out

In 2026 Food and Drug Administration published 591 Federal Register documents: 95 final rules, 29 proposed rules, 467 notices; 4 marked significant. Busiest month: 2026-06.

By month

MonthDocumentsFinal rulesProposedNotices
2026-01270027
2026-02745069
2026-03434633
2026-046911157
2026-05608349
2026-068030248
2026-076310350
2026-08645851
2026-096113345
2026-10509338

Documents, 2026

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

PublishedTypeDocumentEvidence
Oct 23, 2026Proposed RuleHazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availabilityrecord →
Oct 23, 2026Proposed RuleAction Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance for Industry; Availabilityrecord →
Oct 23, 2026NoticeQuestions and Answers Regarding Mandatory Cosmetics Recalls; Guidance for Industry; Availabilityrecord →
Oct 23, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; Correction of Notices-ANDEMBRY; ANZUPGO; ANKTIVA; BIZENGRI; BRINrecord →
Oct 23, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation Scheme for Crecord →
Oct 23, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction and Combination Productsrecord →
Oct 23, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Export Certificates for FDA Regulated Productsrecord →
Oct 21, 2026NoticeRegulatory Considerations for Prescription Drug Use-Related Software; Guidance for Industry; Availabilityrecord →
Oct 20, 2026NoticeNew Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI: Guidance for Industry; Availabrecord →
Oct 16, 2026NoticeFit-for-Purpose Rare Disease Framework Initiative; Public Meeting; Request for Information and Commentsrecord →
Oct 16, 2026NoticeElectronic Common Technical Document; Data Standards; Center for Drug Evaluation and Research and Center for Biologics Evaluation and Researrecord →
Oct 16, 2026NoticeElectronic Common Technical Document (eCTD); Data Standards; Supporting Forward Compatibility for eCTD 4.0record →
Oct 15, 2026NoticeRequest for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products Scientific Advisory Committee (TPSAC)record →
Oct 15, 2026NoticeAuthorization of Emergency Use for Four Animal Drugs for the Prevention and Treatment of New World Screwworm; Availabilityrecord →
Oct 14, 2026RuleFood Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionaterecord →
Oct 14, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Requirementrecord →
Oct 14, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail record →
Oct 14, 2026NoticeAdvisory Committee; Cellular, Tissue, and Gene Therapies Advisory Committee; Renewalrecord →
Oct 14, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Cosmetic record →
Oct 13, 2026NoticePostapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Avairecord →
Oct 13, 2026RuleUse of Salt Substitutes To Reduce the Sodium Content in Standardized Foodsrecord →
Oct 09, 2026NoticeChallenges and Solutions in Lot-Level Food Traceability; Public Meetingrecord →
Oct 09, 2026Proposed RuleRequirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurantrecord →
Oct 09, 2026RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment Kitrecord →
Oct 09, 2026RuleMedical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Userecord →
Oct 09, 2026RuleMedical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganisrecord →
Oct 09, 2026NoticeElite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correctionrecord →
Oct 09, 2026NoticeAmneal Pharmaceuticals of New York, LLC; Withdrawal of Approval of Abbreviated New Drug Application for Celecoxib Capsules, 50 Milligrams, 1record →
Oct 09, 2026NoticePar Health USA LLC, U.S. Agent for PH Health Limited, et al.; Withdrawal of Approval of 37 Abbreviated New Drug Applicationsrecord →
Oct 09, 2026NoticeDetermination That LASIX (Furosemide) Oral Solution, 10 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectivrecord →
Oct 09, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expanded Access to Investirecord →
Oct 09, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; MONOFERRICrecord →
Oct 09, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biologics License Applicatrecord →
Oct 09, 2026NoticeIssuance of Priority Review Voucher; Rare Pediatric Disease Product; ZANVASTRO (Zilganersen)record →
Oct 08, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Program for record →
Oct 08, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Channels of Trade Policy for Commodities With Residues of Perecord →
Oct 07, 2026NoticeDetermination That Oxandrin (Oxandrolone) Tablets, 2.5 Milligrams and 10 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effecrecord →
Oct 06, 2026NoticeDesign and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Informationrecord →
Oct 06, 2026NoticeIssuance of Priority Review Voucher; Rare Pediatric Disease Product; FAYUVI (rebisufligene etisparvovec-hopf)record →
Oct 06, 2026RuleMedical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound System for Non-Thermal, Mechanical Tissue Ablrecord →
Oct 06, 2026RuleMedical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetryrecord →
Oct 06, 2026NoticeDetermination PRALIDOXIME CHLORIDE (Autoinjector) (Pralidoxime Chloride) Solution, 600 Milligrams/2 Milliliters (300 Milligrams/Milliliter),record →
Oct 06, 2026RuleMedical Devices; Immunology and Microbiology Devices; Classification of the High Throughput DNA Sequencing for Hereditary Cancer Predispositrecord →
Oct 06, 2026RuleMedical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systemsrecord →
Oct 06, 2026NoticeTeva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications; Correctionrecord →
Oct 01, 2026NoticeRequest for Nominations for Voting Members of Food and Drug Administration Advisory Committeesrecord →
Oct 01, 2026NoticeRequest for Nominations for Individuals and Consumer Organizations for Advisory Committeesrecord →
Oct 01, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Improvement Progrecord →
Oct 01, 2026NoticeAdvisory Committee; Dermatologic and Ophthalmic Drugs Advisory Committee; Renewalrecord →
Oct 01, 2026NoticeAdvisory Committee; Antimicrobial Drugs Advisory Committee; Renewalrecord →
Sep 30, 2026NoticeDetermination That ISTURISA (Osilodrostat) Tablets, 10 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectivenessrecord →
Sep 30, 2026RuleMedical Devices; Gastroenterology-Urology Devices; Classification of the Flushing and Storage Solution for Vascular Autografts at Room Temperecord →
Sep 29, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Protection of Human Subjects and Institutional Review Boardsrecord →
Sep 29, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Submission of Petitions: Frecord →
Sep 29, 2026NoticeFHTA LLC; Withdrawal of Approval of New Drug Application for MYSOLINE (Primidone) Suspension, 250 Milligrams/5 Millilitersrecord →
Sep 29, 2026NoticeDetermination That SULFADIAZINE (Sulfadiazine) Tablet, 500 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectivenessrecord →
Sep 25, 2026NoticeNaveed Aslam: Final Debarment Orderrecord →
Sep 25, 2026NoticeJeffrey Thies: Final Debarment Orderrecord →
Sep 25, 2026RuleFood Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 Inactive Bakers Yeastrecord →
Sep 25, 2026Proposed RuleFiling of Color Additive Petition From Doehler GmbH; Request To Amend the Color Additive Regulations To Provide for the Safe Use of Calcium record →
Sep 25, 2026NoticeReauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Commentsrecord →
Sep 25, 2026NoticeDermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-New Drug Apprecord →
Sep 25, 2026NoticeRobotically-Assisted Surgical Devices-Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availabilitrecord →
Sep 24, 2026NoticeImproving Patient Access to Deceased Donor Islet Cells and Cell Products; Request for Informationrecord →
Sep 23, 2026NoticeSanjay Kumar: Final Debarment Orderrecord →
Sep 22, 2026Proposed RuleNonclinical Testing Terminologyrecord →
Sep 22, 2026RuleNonclinical Testing Terminologyrecord →
Sep 21, 2026NoticeChemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcementrecord →
Sep 21, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Securirecord →
Sep 21, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption From Preemptionrecord →
Sep 21, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applicationsrecord →
Sep 21, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugsrecord →
Sep 18, 2026NoticeTarget Animal Safety Evaluation for Veterinary Monoclonal Antibody Products; Draft Guidance for Industry; Availabilityrecord →
Sep 18, 2026NoticeBiosimilar User Fee Act III Future Needs in the Development of Interchangeable Products Post-Workshop; Draft Strategy Documentrecord →
Sep 18, 2026NoticeElectronic Submission Template for Medical Device Premarket Approval Applications (PMAs); Draft Guidance for Industry and Food and Drug Admirecord →
Sep 17, 2026RuleMedical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triagrecord →
Sep 17, 2026NoticeRecommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Brecord →
Sep 16, 2026NoticeMicrobiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Commerecord →
Sep 16, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporrecord →
Sep 15, 2026NoticeStatistical Considerations for the Design of Rare Disease Clinical Investigations; Establishment of a Public Docket; Request for Informationrecord →
Sep 14, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Customer/Partner Customer record →
Sep 11, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Qualrecord →
Sep 11, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Trackingrecord →
Sep 11, 2026NoticeAmending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acidrecord →
Sep 11, 2026RuleMedical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Softwarerecord →
Sep 10, 2026RuleMedical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Devicerecord →
Sep 10, 2026RuleMedical Devices; Radiology Devices; Classification of the Vaginal Hydrogel Packing Systemrecord →
Sep 10, 2026RuleMedical Devices; Gastroenterology-Urology Devices; Classification of the Implanted Tibial Electrical Urinary Continence Devicerecord →
Sep 10, 2026RuleMedical Devices; Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT Surgeryrecord →
Sep 10, 2026RuleMedical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Tumor Necrosis Factor Alpha Monoclonal Antibrecord →
Sep 10, 2026RuleMedical Devices; Cardiovascular Devices; Classification of the Extravascular Support for an Arteriovenous Fistula for Vascular Accessrecord →
Sep 10, 2026RuleMedical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablatirecord →
Sep 10, 2026RuleMedical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablationrecord →
Sep 10, 2026NoticeFee Rate for Using a Priority Review Voucher in Fiscal Year 2027record →
Sep 10, 2026Proposed RuleGreen Innovation GmbH; Withdrawal of Food Additive Petition (Animal Use)record →
Sep 09, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ANKTIVArecord →
Sep 09, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ANZUPGOrecord →
Sep 09, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of record →
Sep 09, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ANDEMBRYrecord →
Sep 09, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Productsrecord →
Sep 09, 2026NoticeVaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-2027 record →
Sep 09, 2026NoticeTemporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry; Availabilityrecord →
Sep 04, 2026NoticeAdvancing Development of Botanical Drug Products; Request for Informationrecord →
Sep 03, 2026NoticeDetermination That PHENAPHEN WITH CODEINE NO. 3 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 30 Milligrams, and PHENrecord →
Sep 02, 2026NoticeInternational Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate record →
Sep 02, 2026NoticeInternational Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate record →
Sep 02, 2026NoticeIssuance of Priority Review Voucher; Rare Pediatric Disease Product; GENGLYCOS (parisglasgene brecaparvovec-opnr)record →
Sep 02, 2026NoticeDental Composite Resin Devices and Dental Curing Lights-Premarket Notification (510(k)) Submissions Guidances; Guidances for Industry and Forecord →
Sep 02, 2026NoticePharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage; Draft Guidance for Industry;record →
Sep 02, 2026NoticeDetermination That CARAFATE (Sucralfate) Oral Suspension, 1 Gram/10 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectrecord →
Sep 01, 2026NoticeDetermination That NAMENDA (Memantine Hydrochloride) Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Sarecord →
Aug 31, 2026NoticeRahim Shafa; Denial of Hearing; Final Debarment Orderrecord →
Aug 31, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Removals and Correctionsrecord →
Aug 31, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilitierecord →
Aug 31, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Potential Tobacco Product record →
Aug 31, 2026NoticeAuthorization of Emergency Use for Three Animal Drugs for the Prevention and Treatment of New World Screwworm; Availabilityrecord →
Aug 28, 2026NoticeCompounding Animal Drugs From Bulk Drug Substances: Compounding Under CGMP in Federally-Registered Facilities; Draft Guidance for Industry; record →
Aug 28, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups and Interviews as Used by the Food and Drug Admrecord →
Aug 28, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, andrecord →
Aug 28, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Associated With record →
Aug 28, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Importation of Prescriptiorecord →
Aug 28, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Qualitative Feedback on Agency Service Deliveryrecord →
Aug 27, 2026NoticeDrugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Second Extension of Effective Darecord →
Aug 26, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Allegations of Regulatory Misconduct Voluntarily Submitted trecord →
Aug 26, 2026NoticeInternational Drug Scheduling; Single Convention on Narcotic Drugs; Convention on Psychotropic Substances; Clobromazolam (Phenazolam); Cychlrecord →
Aug 26, 2026NoticeDetermination That CABAZITAXEL (Cabazitaxel) Solution (Injection), 60 Milligrams/6 Milliliters (10 Milligrams/Milliliter), Was Not Withdrawnrecord →
Aug 24, 2026NoticeEvaluation of Therapeutic Equivalence; Guidance for Industry; Availabilityrecord →
Aug 24, 2026NoticeProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availabilityrecord →
Aug 24, 2026NoticeFood and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 066record →
Aug 21, 2026NoticeAdvisory Committee; Oncologic Drugs Advisory Committee; Renewalrecord →
Aug 20, 2026NoticeFrequently Asked Questions-Developing Potential Cellular and Gene Therapy Products; Final Guidance for Industry; Availabilityrecord →
Aug 20, 2026NoticePotency Assessment of Active Immunotherapy Products; Draft Guidance for Industry; Availabilityrecord →
Aug 20, 2026NoticeAdvisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee; Renewalrecord →
Aug 20, 2026NoticeAdvisory Committee; Cardiovascular and Renal Drugs Advisory Committee; Renewalrecord →
Aug 19, 2026Proposed RuleGNT USA, LLC.; Filing of Color Additive Petitionrecord →
Aug 19, 2026RuleFood Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelaterecord →
Aug 19, 2026Proposed RuleInternational Association of Color Manufacturers; Filing of Color Additive Petitionrecord →
Aug 19, 2026Proposed RuleGardenia Blue Interest Group; Filing of Color Additive Petitionrecord →
Aug 18, 2026NoticeTestosterone Use in Menopausal Women; Public Workshop; Request for Commentsrecord →
Aug 18, 2026NoticeDetermining Whether To Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; Availabilityrecord →
Aug 17, 2026NoticeType VII Veterinary Master File for Research and Development and Risk Reviews; Guidance for Industry; Availabilityrecord →
Aug 17, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Imports and Electronic Import Entriesrecord →
Aug 17, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; BIZENGRIrecord →
Aug 17, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Rerecord →
Aug 17, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirementsrecord →
Aug 17, 2026NoticeAgency Information Collection Activities; Announcement of Office of Management and Budget Approvalsrecord →
Aug 17, 2026RuleHematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therrecord →
Aug 17, 2026Proposed RuleGastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended record →
Aug 17, 2026Proposed RuleMedical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Crecord →
Aug 14, 2026NoticeContainer Closure Systems for Human Drugs and Biological Products; Draft Guidance for Industry; Availabilityrecord →
Aug 14, 2026NoticeDetermination That LASIX (Furosemide) Tablets, 20 Milligrams, 40 Milligrams, and 80 Milligrams, Were Not Withdrawn From Sale for Reasons of record →
Aug 14, 2026NoticeReauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Commentsrecord →
Aug 14, 2026NoticeDetermination That ANSAID (Flurbiprofen) Tablets, 50 Milligrams and 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Efrecord →
Aug 13, 2026NoticeFormal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Guidance forrecord →
Aug 13, 2026NoticeKremers Urban Pharmaceuticals, Inc.; Grant of Hearing Request Regarding a Proposal To Withdraw Approval of an Abbreviated New Drug Applicatirecord →
Aug 12, 2026RuleGuide To Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce; Guidance for Industry; Availabilityrecord →
Aug 11, 2026Proposed RuleSubstances Generally Recognized as Saferecord →
Aug 11, 2026NoticeReauthorization of the Generic Drug User Fee Amendments; Public Meeting; Request for Commentsrecord →
Aug 10, 2026Proposed RuleRadiology Devices; Reclassification of Digital Breast Tomosynthesis Systemrecord →
Aug 10, 2026NoticeMolecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Requesrecord →
Aug 10, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; DAYVIGOrecord →
Aug 10, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; BRINSUPRIrecord →
Aug 10, 2026NoticeDetermination That OZOBAX (Baclofen) Oral Solution, 5 Milligrams/5 Milliliters Was Not Withdrawn From Sale for Reasons of Safety or Effectivrecord →
Aug 06, 2026NoticeEvaluating the Safety of Antimicrobial New Animal Drugs With Regard to their Microbiological Effects on Bacteria of Human Health Concern; Gurecord →
Aug 06, 2026RuleMedical Devices; Radiology Devices; Classification of the Fludeoxyglucose F18-Guided Radiation Therapy Systemrecord →
Aug 06, 2026NoticeAuthorization of Emergency Use of an In Vitro Diagnostic Device in Response to an Outbreak of Mpox; Availabilityrecord →
Aug 05, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administratirecord →
Aug 05, 2026NoticeEstablishment of a Quantitative Medicine Innovation Network: Scope, Feasibility, and Opportunities; Request for Informationrecord →
Aug 05, 2026RuleMicro-Tracers, Inc.; Response to Objections and Requests for a Public Hearingrecord →
Aug 03, 2026NoticeAssessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Revised Draft Guidance for Indusrecord →
Aug 03, 2026NoticeAssessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs; Guidance for Industry; Availabilityrecord →
Aug 03, 2026NoticeBiosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Draft Guidancrecord →
Aug 03, 2026NoticeAngela Anatilde Baquero: Final Debarment Orderrecord →
Aug 03, 2026NoticeRicardo Andres Acuna: Final Debarment Orderrecord →
Aug 03, 2026Proposed RuleModification of Certain Terminology in Title 21; Reopening of the Comment Periodrecord →
Jul 30, 2026NoticePrescription Drug User Fee Rates for Fiscal Year 2027record →
Jul 30, 2026NoticeMedical Device User Fee Rates for Fiscal Year 2027record →
Jul 30, 2026NoticeFood Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2027record →
Jul 30, 2026NoticeFood Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2027record →
Jul 30, 2026NoticeAnimal Drug User Fee Rates and Payment Procedures for Fiscal Year 2027record →
Jul 30, 2026NoticeAnimal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2027record →
Jul 30, 2026NoticeOutsourcing Facility Fee Rates for Fiscal Year 2027record →
Jul 30, 2026NoticeGeneric Drug User Fee Rates for Fiscal Year 2027record →
Jul 30, 2026NoticeOver-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027record →
Jul 30, 2026NoticeFood Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2027record →
Jul 30, 2026NoticeBiosimilar User Fee Rates for Fiscal Year 2027record →
Jul 30, 2026NoticeButylated Hydroxytoluene (BHT); Request for Information; Reopening of Comment Periodrecord →
Jul 29, 2026NoticeProduct-Specific Guidances; Revised Draft Guidances for Industry; Availabilityrecord →
Jul 29, 2026NoticeStatement of Organization, Functions, and Delegations of Authorityrecord →
Jul 29, 2026RuleMedical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapyrecord →
Jul 28, 2026NoticeFee Rate for Using a Priority Review Voucher in Fiscal Year 2026; Correctionrecord →
Jul 28, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Expanded Access to Investigational Drugs for Treatment Userecord →
Jul 28, 2026NoticePediatric Advisory Committee (PAC); Notice of Meeting; Establishment of a Public Docket; Request for Commentsrecord →
Jul 28, 2026NoticeCancer Clinical Trial Eligibility Criteria: Performance Status; Guidance for Industry, Institutional Review Boards, and Clinical Investigatorecord →
Jul 28, 2026NoticeCancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Guidance for Industry, Institutional Review Boards,record →
Jul 28, 2026NoticeCancer Clinical Trial Eligibility Criteria: Laboratory Values; Guidance for Industry, Institutional Review Boards, and Clinical Investigatorrecord →
Jul 27, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research record →
Jul 27, 2026RuleMedical Devices; Gastroenterology-Urology Devices; Classification of the Non-Medicated Topical Formulation for Treatment of Erectile Dysfuncrecord →
Jul 27, 2026RuleMedical Devices; General Hospital and Personal Use Devices; Classification of the Active Noise Attenuation System for Infant Incubatorsrecord →
Jul 24, 2026RuleMedical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Chronic Kidney record →
Jul 24, 2026RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Over-the-Counter Test To Detect SARS-CoV-2 From Clinical Specimerecord →
Jul 24, 2026RuleMedical Devices; General Hospital and Personal Use Devices; Classification of the Diabetes Digital Behavioral Therapeutic Devicerecord →
Jul 24, 2026RuleMedical Devices; Orthopedic Devices; Classification of the Intraoperative Surgical Angle Measurement Toolrecord →
Jul 24, 2026NoticeFrancis Esteban Matos: Final Debarment Orderrecord →
Jul 24, 2026NoticeCellular, Tissue, and Gene Therapies Advisory Committee; Amendment of Notice-Biologics License Application (BLA) 125842 From Capricor, Inc. record →
Jul 24, 2026NoticeCellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologicsrecord →
Jul 24, 2026Proposed RuleEvonik Corporation, Filing of Food Additive Petition (Animal Use)record →
Jul 23, 2026NoticeAdvisory Committee; Peripheral and Central Nervous System Drugs Advisory Committee; Termination and Reestablishmentrecord →
Jul 23, 2026NoticeFDA's Strategy Document on Facilitating Chemistry, Manufacturing, and Controls Readiness for Products With Accelerated Clinical Developmentrecord →
Jul 23, 2026Proposed RuleProposal To Revoke the Color Additive Listing for Use of Citrus Red No. 2 on the Skins of Mature Orangesrecord →
Jul 23, 2026RuleRevocation of the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausagesrecord →
Jul 22, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notifications Surecord →
Jul 22, 2026NoticeDetermination That RASUVO (Methotrexate) Solution, 27.5 Milligrams/0.55 Milliliter (27.5 Milligrams/0.55 Milliliter), Was Not Withdrawn Fromrecord →
Jul 21, 2026NoticeExpedited Investigational New Drug Pilot Program; Request for Information; Extension of the Comment Periodrecord →
Jul 20, 2026RuleFood Standards of Identity Modernization; Pasteurized Orange Juicerecord →
Jul 17, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Cosmetic Productsrecord →
Jul 17, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Voluntary National Retail Food Regulatory Program Standardsrecord →
Jul 17, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Voluntary Improvement Programrecord →
Jul 17, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirementsrecord →
Jul 17, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Devices: (Medical Product record →
Jul 17, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Accreditation Scheme for Conformity Assessment Programrecord →
Jul 16, 2026NoticeProcess for FDA Data Requests To Inform Certain Over-the-Counter Monograph Drug Activities; Procedurerecord →
Jul 14, 2026NoticeTopical Dermatologic Corticosteroids: In Vivo Bioequivalence; Guidance for Industry; Availabilityrecord →
Jul 14, 2026NoticeFormal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugsrecord →
Jul 14, 2026NoticeConsiderations for Potential Future Therapeutic Use of Psychedelic Drugs; Public Hearing; Request for Commentsrecord →
Jul 14, 2026NoticePsychedelic Drugs: Considerations for Clinical Investigations; Guidance for Industry; Availabilityrecord →
Jul 13, 2026Proposed RuleDrug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Esrecord →
Jul 09, 2026NoticeDetermination That TOVALT ODT (Zolpidem Tartrate) Orally Disintegrating Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Salrecord →
Jul 08, 2026NoticeMedical Device User Fee Amendments; Public Meeting; Request for Commentsrecord →
Jul 08, 2026NoticeCellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologicsrecord →
Jul 07, 2026RuleNew Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsorrecord →
Jul 06, 2026NoticeDetermination That VASOPRESSIN IN SODIUM CHLORIDE (vasopressin) 0.9%, Injection, 50 units/50 milliliters (1 unit/milliliters) Was Not Withdrrecord →
Jul 06, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Approval of Medirecord →
Jul 06, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Biologics License Applications, Procedures and Requirementsrecord →
Jul 06, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Practices arecord →
Jul 06, 2026NoticeExpedited Investigational New Drug Pilot Program; Request for Information; Correctionrecord →
Jul 06, 2026NoticeEndo Operations Limited, et al.; Withdrawal of Approval of 34 New Drug Applicationsrecord →
Jul 01, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medication Guides for Presrecord →
Jun 30, 2026RuleMedical Devices; General and Plastic Surgery Devices; Classification of the Skin Patch for Treatment of Hyperhidrosisrecord →
Jun 30, 2026RuleMedical Devices; Anesthesiology Devices; Classification of the Monitor for Opioid Induced Impairment of Oxygenationrecord →
Jun 29, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Minorrecord →
Jun 29, 2026NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; VYALEVrecord →
Jun 29, 2026Proposed RuleEstablishment Registration and Product Listing for Tobacco Productsrecord →
Jun 29, 2026NoticeCellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologicsrecord →
Jun 29, 2026RuleMedical Devices; Orthopedic Devices; Classification of the Medial Knee Implanted Shock Absorberrecord →
Jun 26, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Time and Extent Applications for Nonprescription Drug Producrecord →
Jun 26, 2026RuleMedical Devices; General Hospital and Personal Use Devices; Classification of the Foam or Gel Chemical Sterilant/High Level Disinfectantrecord →
Jun 26, 2026RuleMedical Devices; Clinical Chemistry and Toxicology Devices; Classification of the Prognostic Test for Development or Progression of Preeclamrecord →
Jun 26, 2026RuleMedical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for the Treatment of Fibromyalgia Symptorecord →
Jun 26, 2026RuleMedical Devices; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Testrecord →
Jun 26, 2026RuleMedical Devices; General and Plastic Surgery Devices; Classification of the Breast Implant Suction Retrieval Systemrecord →
Jun 26, 2026RuleMedical Devices; Neurological Devices; Classification of the External Lower Extremity Nerve Stimulator for Restless Legs Syndromerecord →
Jun 26, 2026RuleMedical Devices; General Hospital and Personal Use Devices; Classification of the Infant Supine Sleep Systemrecord →
Jun 26, 2026NoticeRevocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availabilityrecord →
Jun 26, 2026NoticeDrugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Extension of Effective Date of Frecord →
Jun 26, 2026NoticeList of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension ofrecord →
Jun 26, 2026NoticeDetermination That RECTIV (Nitroglycerin) Ointment, 0.4%, Was Not Withdrawn From Sale for Reasons of Safety or Effectivenessrecord →
Jun 26, 2026NoticeDetermination That Prednisolone Tablet, 5 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectivenessrecord →
Jun 25, 2026Proposed RuleSterigenics U.S., LLC; Filing of Food Additive Petitionrecord →
Jun 24, 2026NoticeQuantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH)record →
Jun 24, 2026NoticeMaster Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Availabilityrecord →
Jun 24, 2026NoticeExpedited Investigational New Drug Pilot Program; Request for Informationrecord →
Jun 24, 2026NoticeDemonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Revised Draft Guidance for Industry; Availabilitrecord →
Jun 24, 2026NoticeInternational Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Antrecord →
Jun 24, 2026NoticeInternational Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Antrecord →
Jun 24, 2026NoticeInternational Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Antrecord →
Jun 24, 2026NoticeInternational Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Antrecord →
Jun 24, 2026NoticeInternational Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Antrecord →
Jun 24, 2026NoticeInternational Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Antrecord →
Jun 24, 2026NoticeInternational Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Antrecord →
Jun 24, 2026NoticeInternational Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Antrecord →
Jun 24, 2026NoticeInternational Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Antrecord →
Jun 23, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Potential Tobacco Product Violations Reporting Formrecord →
Jun 23, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification of Identity,record →
Jun 22, 2026NoticeEpizyme, Inc.; Withdrawal of Approval of New Drug Application for TAZVERIK (Tazemetostat) Tablet, 200 Milligramsrecord →
Jun 22, 2026RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Simple In Vitro Diagnostic Device for the Detection of Secreted record →
Jun 22, 2026RuleMedical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Light-Projecting Measuring Devicerecord →
Jun 22, 2026RuleMedical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Traction Devicerecord →
Jun 18, 2026NoticeAdvisory Committee; Science Board to the Food and Drug Administration; Renewalrecord →
Jun 18, 2026NoticeSpecGx LLC; Withdrawal of Approval of Abbreviated New Drug Application for Methylphenidate Hydrochloride Extended-Release Tablets, 27 Milligrecord →
Jun 18, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturingrecord →
Jun 18, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturingrecord →
Jun 18, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animalsrecord →
Jun 18, 2026NoticeAuthorization of Emergency Use for Two Animal Drugs for the Prevention and Treatment of New World Screwworm; Availabilityrecord →
Jun 17, 2026RuleMedical Devices; Gastroenterology-Urology Devices; Classification of the Ingestible Gastrointestinal Blood Detection Capsulerecord →
Jun 17, 2026RuleMedical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predeterminrecord →
Jun 17, 2026NoticeAndrew Jonathan Morgan: Final Debarment Orderrecord →
Jun 16, 2026NoticeMasuu Global Solutions LLC, U.S. Agent for Extrovis AG, et al.; Withdrawal of Approval of 11 Abbreviated New Drug Applications; Correctionrecord →
Jun 15, 2026NoticeForms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availabilityrecord →
Jun 15, 2026RuleAmendment and Revocation of Organizational Information Regulationsrecord →
Jun 11, 2026NoticeRecommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments; Reopening of the Comment Periodrecord →
Jun 11, 2026NoticeDrug Repurposing for Unmet Medical Needs; Request for Information; Extension of Comment Periodrecord →
Jun 11, 2026RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Simple Point-of-Care Device to Directly Detect SARS-CoV-2 Viral record →
Jun 11, 2026RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Spinal Muscular Atrophy Newborn Screening Test Systemrecord →
Jun 11, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment, Maintenancerecord →
Jun 11, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Procedures for the Safe Prrecord →
Jun 10, 2026NoticeAmending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Informationrecord →
Jun 10, 2026RuleMedical Devices; Ear, Nose, and Throat Devices; Classification of the Combined Acoustic and Electrical External Stimulation Device for the Rrecord →
Jun 08, 2026NoticeDetermination That Protamine Sulfate (Protamine Sulfate) Intravenous; Solution, 50 Milligrams/5 Milliliters, and Other Drug Products Were Norecord →
Jun 05, 2026RuleMedical Devices; Orthopedic Devices; Classification of the Absorbable Metallic Bone Fixation Fastenerrecord →
Jun 05, 2026NoticeIntent To Exempt Certain Unclassified Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Admirecord →
Jun 05, 2026RuleMedical Devices; Orthopedic Devices; Classification of the Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented or Uncrecord →
Jun 05, 2026RuleMedical Devices; Orthopedic Devices; Classification of the Resorbable Calcium Salt Bone Void Filler Containing a Single Approved Aminoglycosrecord →
Jun 03, 2026NoticeVanda Pharmaceuticals, Inc.; Grant of Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLrecord →
Jun 03, 2026NoticeLeveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry; Avairecord →
Jun 03, 2026NoticeDrug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guirecord →
Jun 03, 2026NoticeElite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applicationsrecord →
Jun 03, 2026NoticeThird Annual Animal Drug User Fee Educational Conference; Public Meetingrecord →
Jun 03, 2026RuleNew Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Changrecord →
Jun 03, 2026NoticeM15 General Principles for Model-Informed Drug Development; International Council for Harmonisation; Guidance for Industry; Availabilityrecord →
Jun 01, 2026NoticeOncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availabrecord →
Jun 01, 2026RuleMedical Devices; Ear, Nose, and Throat Devices; Classification of the Oropharyngeal Electrical Stimulatorrecord →
Jun 01, 2026RuleMedical Devices; Hematology and Pathology Devices; Classification of the Von Willebrand Factor Assayrecord →
Jun 01, 2026RuleMedical Devices; Dental Devices; Classification of the Intraoral Cooling Devicerecord →
Jun 01, 2026RuleMedical Devices; Gastroenterology-Urology Devices; Classification of the Orally Ingested Transient Device for Constipationrecord →
Jun 01, 2026RuleMedical Devices; Anesthesiology Devices; Classification of the Adjunctive Pain Measurement Device for Anesthesiologyrecord →
Jun 01, 2026RuleMedical Devices; Anesthesiology Devices; Classification of the Real-Time Ultrasound Anatomy Visualization and Labeling Device for Ultrasoundrecord →
Jun 01, 2026RuleMedical Devices; General Hospital and Personal Use Devices; Classification of the Rigid Sterilization Container With Electronic Monitoringrecord →
May 29, 2026NoticeAdvisory Committee; Psychopharmacologic Drugs Advisory Committee; Renewalrecord →
May 29, 2026RuleMedical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptomsrecord →
May 29, 2026NoticeBioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Guidance for Industry; record →
May 29, 2026NoticeStatistical Approaches To Establishing Bioequivalence; Guidance for Industry; Availabilityrecord →
May 29, 2026NoticeContent of Human Factors Information in Medical Device Marketing Submissions; Guidance for Industry and Food and Drug Administration Staff; record →
May 29, 2026NoticePatient-Focused Drug Development for Nonhealing Chronic Wounds; Public Meeting; Request for Commentsrecord →
May 28, 2026NoticeAI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information; Extension of Comment Periodrecord →
May 28, 2026NoticeChallenges and Solutions in Lot-Level Food Traceability; Public Meeting and Request for Commentsrecord →
May 28, 2026Proposed RuleColor Additive Petition from Environmental Defense Fund, et al.; Request To Amend the Color Additive Regulations To Remove the Solvents Ethyrecord →
May 28, 2026Proposed RuleFood Additive Petition From Environmental Defense Fund, et al.; Request To Amend the Food Additive Regulations To Remove the Solvents Benzenrecord →
May 28, 2026RuleMedical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Suturing Device for Altering Gastric Anatomy for Weight record →
May 27, 2026NoticeDrugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Syntest D.S. and Syntest H.S. Tarecord →
May 26, 2026NoticeAdvisory Committee; Drug Safety and Risk Management Advisory Committee; Renewalrecord →
May 26, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Frecord →
May 26, 2026NoticeAdvisory Committee; Pulmonary-Allergy Drugs Advisory Committee; Renewalrecord →
May 22, 2026NoticeNotice of Decision Not To Designate Hepatitis Delta Virus Diseases as an Addition to the Current List of Tropical Diseases in the Federal Forecord →
May 22, 2026NoticeProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availabilityrecord →
May 22, 2026NoticeProtein Efficiency Ratio Rat Bioassay Studies To Demonstrate That a New Infant Formula Supports the Quality Factor of Sufficient Biological record →
May 22, 2026NoticeM11 Clinical Electronic Structured Harmonised Protocol (CeSHarP); International Council for Harmonisation; Guidance for Industry; Availabilirecord →
May 22, 2026NoticeVaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Safetrecord →
May 21, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Required Warnings for Cigarecord →
May 21, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturingrecord →
May 21, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience/Events record →
May 21, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Patent Term Restoration; Drecord →
May 15, 2026NoticeOscar Bobo: Final Debarment Orderrecord →
May 13, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; The Real Cost Campaign Outrecord →
May 13, 2026NoticeButylated Hydroxytoluene (BHT); Request for Informationrecord →
May 13, 2026NoticeAzodicarbonamide (ADA); Request for Informationrecord →
May 13, 2026NoticeBiomarker Incubator: Urinary Kidney Safety Biomarkers; Request for Informationrecord →
May 13, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reportingrecord →
May 13, 2026NoticeModified Risk Tobacco Product Application: Renewal Applications for VLN® King and VLN® Menthol King, Cigarette Products Submitted by 22nd Cerecord →
May 12, 2026RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microorganism Nucleic Acids and Rerecord →
May 12, 2026NoticeDrug Repurposing for Unmet Medical Needs; Request for Informationrecord →
May 12, 2026NoticeEnforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization; Guidance for Industry; Availabilityrecord →
May 12, 2026Notice21st Century Cures Act: Annual Compilation of Notices of Updates From the Susceptibility Test Interpretive Criteria web pagerecord →
May 11, 2026NoticeIssuance of Priority Review Voucher; Rare Pediatric Disease Product; AVLAYAH (tividenofusp alfa-eknm)record →
May 11, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications On record →
May 11, 2026NoticeClostridioides Difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, or Prevention; Guidance for Industry; Availabilrecord →
May 11, 2026NoticePostapproval Pregnancy Safety Studies; Guidance for Industry; Availabilityrecord →
May 11, 2026NoticePulmonary Tuberculosis: Developing Drugs for Treatment; Guidance for Industry; Availabilityrecord →
May 11, 2026NoticeAnimal Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Drug User Fee Act Reauthorization; Request for Notification of Starecord →
May 11, 2026NoticeAnimal Generic Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Generic Drug User Fee Act Reauthorization; Request for Notrecord →
May 08, 2026RuleMedical Devices; Obstetrical and Gynecological Devices; Classification of the External Condom for Anal Intercourse or Vaginal Intercourserecord →
May 08, 2026NoticeDetermination That Leucovorin Calcium, Oral Solution, Equivalent to 60 Milligrams Base/Vial, Was Not Withdrawn From Sale for Reasons of Saferecord →
May 07, 2026NoticeDetermination That MICARDIS (Telmisartan), Tablets, 20 Milligrams and 80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Erecord →
May 07, 2026NoticeTeva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applicationsrecord →
May 07, 2026NoticePatient-Matched Guides for Orthopedic Implants; Guidance for Industry and Food and Drug Administration Staff; Availabilityrecord →
May 07, 2026NoticeAdvisory Committee; Blood Products Advisory Committee; Renewalrecord →
May 06, 2026RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Device To Preserve and Stabilize Relative Abundances of Microbiarecord →
May 06, 2026RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Circulating Tumor Cell Enrichment Devicerecord →
May 06, 2026RuleMedical Devices; Ophthalmic Devices; Classification of the Corneal Storage Medium With Preservatives Including Antifungalsrecord →
May 06, 2026Proposed RuleModification of Certain Terminology in Title 21record →
May 06, 2026NoticeIssuance of Priority Review Voucher; Rare Pediatric Disease Product; OTARMENI (lunsotogene parvec-cwha)record →
May 06, 2026NoticeDetermination That DEXAMETHASONE (Dexamethasone) Elixir, 0.5 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or record →
May 04, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; National Youth Tobacco Surveyrecord →
May 01, 2026RuleMedical Devices; General and Plastic Surgery Devices; Classification of the Phototherapy Device for Reducing the Appearance of Acute Post-Surecord →
May 01, 2026NoticeMedical Devices; Exemptions From Premarket Notification: Certain Class II Devices; Request for Commentsrecord →
May 01, 2026NoticeObesity and Drug Dosing: Clinical Pharmacology Considerations; Request for Commentsrecord →
May 01, 2026NoticeImpacts of Patient-Focused Drug Development Meetings; Establishment of a Public Docket; Request for Information and Commentsrecord →
May 01, 2026NoticeList of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Actrecord →
Apr 30, 2026NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Requirements for Nonclinical Laborarecord →
Apr 30, 2026NoticeAdvisory Committee; Pharmacy Compounding Advisory Committee; Renewalrecord →
Apr 30, 2026NoticeDetermination FENOGLIDE (Fenofibrate) Tablets, 40 Milligrams and 120 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectrecord →
Apr 30, 2026NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Hazard Analysis and Criticrecord →
Apr 30, 2026RuleMedical Devices; Radiology Devices; Classification of the Radiation Therapy Marking Devicerecord →
Apr 30, 2026RuleMedical Devices; Neurological Devices; Classification of the Brain Temperature Measurement Systemrecord →
Apr 30, 2026RuleMedical Devices; Cardiovascular Devices; Classification of the Laser-Powered Inferior Vena Cava Filter Retrieval Catheterrecord →
Apr 30, 2026NoticeDetermination That OZEMPIC (Semaglutide) Solution, 2 Milligrams Per 1.5 Milliliters Was Not Withdrawn From Sale for Reasons of Safety or Effrecord →
Apr 30, 2026NoticeChemoCentryx, Inc.; Proposal To Withdraw Approval of New Drug Application for TAVNEOS (Avacopan) Capsule, 10 Milligrams; Opportunity for a Hrecord →
Apr 29, 2026NoticeAI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Informationrecord →
Apr 27, 2026NoticeVaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Uniterecord →
Apr 27, 2026NoticeAdvisory Committee; Anesthetic and Analgesic Drug Products Advisory Committee; Renewalrecord →
Apr 24, 2026NoticeEgis Pharmaceuticals Limited, et al.; Withdrawal of Approval of Three Abbreviated New Drug Applicationsrecord →
Apr 24, 2026NoticeReport on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availabilityrecord →
Apr 23, 2026NoticeKimberly Schaff Kiehl: Final Debarment Orderrecord →
Apr 23, 2026NoticeHarmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke; Established List Additions and Request for Commentsrecord →
Apr 23, 2026NoticeCommissioner's National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for Comments; Amendmentrecord →
Apr 22, 2026RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Alzheimer's Disease Pathology Assessment Testrecord →
Apr 22, 2026RuleMedical Devices; Ophthalmic Devices; Classification of the Digital Therapy Device for Amblyopiarecord →
Apr 22, 2026RuleMedical Devices; Anesthesiology Devices; Classification of the Device for Sleep Apnea Testing Based on Mandibular Movementrecord →
Apr 22, 2026RuleMedical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Setmelanotide Eligibility Gene Variant Detection record →
Apr 20, 2026NoticeCompliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators; Draft Guidance for Industrecord →

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