| Oct 23, 2026 | Proposed Rule | Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability | record → |
| Oct 23, 2026 | Proposed Rule | Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability | record → |
| Oct 23, 2026 | Notice | Questions and Answers Regarding Mandatory Cosmetics Recalls; Guidance for Industry; Availability | record → |
| Oct 23, 2026 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; Correction of Notices-ANDEMBRY; ANZUPGO; ANKTIVA; BIZENGRI; BRIN | record → |
| Oct 23, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation Scheme for C | record → |
| Oct 23, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction and Combination Products | record → |
| Oct 23, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Export Certificates for FDA Regulated Products | record → |
| Oct 21, 2026 | Notice | Regulatory Considerations for Prescription Drug Use-Related Software; Guidance for Industry; Availability | record → |
| Oct 20, 2026 | Notice | New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI: Guidance for Industry; Availab | record → |
| Oct 16, 2026 | Notice | Fit-for-Purpose Rare Disease Framework Initiative; Public Meeting; Request for Information and Comments | record → |
| Oct 16, 2026 | Notice | Electronic Common Technical Document; Data Standards; Center for Drug Evaluation and Research and Center for Biologics Evaluation and Resear | record → |
| Oct 16, 2026 | Notice | Electronic Common Technical Document (eCTD); Data Standards; Supporting Forward Compatibility for eCTD 4.0 | record → |
| Oct 15, 2026 | Notice | Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products Scientific Advisory Committee (TPSAC) | record → |
| Oct 15, 2026 | Notice | Authorization of Emergency Use for Four Animal Drugs for the Prevention and Treatment of New World Screwworm; Availability | record → |
| Oct 14, 2026 | Rule | Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate | record → |
| Oct 14, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Requirement | record → |
| Oct 14, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail | record → |
| Oct 14, 2026 | Notice | Advisory Committee; Cellular, Tissue, and Gene Therapies Advisory Committee; Renewal | record → |
| Oct 14, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Cosmetic | record → |
| Oct 13, 2026 | Notice | Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Avai | record → |
| Oct 13, 2026 | Rule | Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods | record → |
| Oct 09, 2026 | Notice | Challenges and Solutions in Lot-Level Food Traceability; Public Meeting | record → |
| Oct 09, 2026 | Proposed Rule | Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurant | record → |
| Oct 09, 2026 | Rule | Medical Devices; Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment Kit | record → |
| Oct 09, 2026 | Rule | Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use | record → |
| Oct 09, 2026 | Rule | Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganis | record → |
| Oct 09, 2026 | Notice | Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction | record → |
| Oct 09, 2026 | Notice | Amneal Pharmaceuticals of New York, LLC; Withdrawal of Approval of Abbreviated New Drug Application for Celecoxib Capsules, 50 Milligrams, 1 | record → |
| Oct 09, 2026 | Notice | Par Health USA LLC, U.S. Agent for PH Health Limited, et al.; Withdrawal of Approval of 37 Abbreviated New Drug Applications | record → |
| Oct 09, 2026 | Notice | Determination That LASIX (Furosemide) Oral Solution, 10 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiv | record → |
| Oct 09, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expanded Access to Investi | record → |
| Oct 09, 2026 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; MONOFERRIC | record → |
| Oct 09, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biologics License Applicat | record → |
| Oct 09, 2026 | Notice | Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ZANVASTRO (Zilganersen) | record → |
| Oct 08, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Program for | record → |
| Oct 08, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Channels of Trade Policy for Commodities With Residues of Pe | record → |
| Oct 07, 2026 | Notice | Determination That Oxandrin (Oxandrolone) Tablets, 2.5 Milligrams and 10 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effec | record → |
| Oct 06, 2026 | Notice | Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information | record → |
| Oct 06, 2026 | Notice | Issuance of Priority Review Voucher; Rare Pediatric Disease Product; FAYUVI (rebisufligene etisparvovec-hopf) | record → |
| Oct 06, 2026 | Rule | Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound System for Non-Thermal, Mechanical Tissue Abl | record → |
| Oct 06, 2026 | Rule | Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry | record → |
| Oct 06, 2026 | Notice | Determination PRALIDOXIME CHLORIDE (Autoinjector) (Pralidoxime Chloride) Solution, 600 Milligrams/2 Milliliters (300 Milligrams/Milliliter), | record → |
| Oct 06, 2026 | Rule | Medical Devices; Immunology and Microbiology Devices; Classification of the High Throughput DNA Sequencing for Hereditary Cancer Predisposit | record → |
| Oct 06, 2026 | Rule | Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems | record → |
| Oct 06, 2026 | Notice | Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications; Correction | record → |
| Oct 01, 2026 | Notice | Request for Nominations for Voting Members of Food and Drug Administration Advisory Committees | record → |
| Oct 01, 2026 | Notice | Request for Nominations for Individuals and Consumer Organizations for Advisory Committees | record → |
| Oct 01, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Improvement Prog | record → |
| Oct 01, 2026 | Notice | Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory Committee; Renewal | record → |
| Oct 01, 2026 | Notice | Advisory Committee; Antimicrobial Drugs Advisory Committee; Renewal | record → |
| Sep 30, 2026 | Notice | Determination That ISTURISA (Osilodrostat) Tablets, 10 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | record → |
| Sep 30, 2026 | Rule | Medical Devices; Gastroenterology-Urology Devices; Classification of the Flushing and Storage Solution for Vascular Autografts at Room Tempe | record → |
| Sep 29, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Protection of Human Subjects and Institutional Review Boards | record → |
| Sep 29, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Submission of Petitions: F | record → |
| Sep 29, 2026 | Notice | FHTA LLC; Withdrawal of Approval of New Drug Application for MYSOLINE (Primidone) Suspension, 250 Milligrams/5 Milliliters | record → |
| Sep 29, 2026 | Notice | Determination That SULFADIAZINE (Sulfadiazine) Tablet, 500 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | record → |
| Sep 25, 2026 | Notice | Naveed Aslam: Final Debarment Order | record → |
| Sep 25, 2026 | Notice | Jeffrey Thies: Final Debarment Order | record → |
| Sep 25, 2026 | Rule | Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 Inactive Bakers Yeast | record → |
| Sep 25, 2026 | Proposed Rule | Filing 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, 2026 | Notice | Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments | record → |
| Sep 25, 2026 | Notice | Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-New Drug App | record → |
| Sep 25, 2026 | Notice | Robotically-Assisted Surgical Devices-Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availabilit | record → |
| Sep 24, 2026 | Notice | Improving Patient Access to Deceased Donor Islet Cells and Cell Products; Request for Information | record → |
| Sep 23, 2026 | Notice | Sanjay Kumar: Final Debarment Order | record → |
| Sep 22, 2026 | Proposed Rule | Nonclinical Testing Terminology | record → |
| Sep 22, 2026 | Rule | Nonclinical Testing Terminology | record → |
| Sep 21, 2026 | Notice | Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement | record → |
| Sep 21, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Securi | record → |
| Sep 21, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption From Preemption | record → |
| Sep 21, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications | record → |
| Sep 21, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs | record → |
| Sep 18, 2026 | Notice | Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products; Draft Guidance for Industry; Availability | record → |
| Sep 18, 2026 | Notice | Biosimilar User Fee Act III Future Needs in the Development of Interchangeable Products Post-Workshop; Draft Strategy Document | record → |
| Sep 18, 2026 | Notice | Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs); Draft Guidance for Industry and Food and Drug Admi | record → |
| Sep 17, 2026 | Rule | Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triag | record → |
| Sep 17, 2026 | Notice | Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the B | record → |
| Sep 16, 2026 | Notice | Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comme | record → |
| Sep 16, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Repor | record → |
| Sep 15, 2026 | Notice | Statistical Considerations for the Design of Rare Disease Clinical Investigations; Establishment of a Public Docket; Request for Information | record → |
| Sep 14, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Customer/Partner Customer | record → |
| Sep 11, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Qual | record → |
| Sep 11, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Tracking | record → |
| Sep 11, 2026 | Notice | Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acid | record → |
| Sep 11, 2026 | Rule | Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software | record → |
| Sep 10, 2026 | Rule | Medical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device | record → |
| Sep 10, 2026 | Rule | Medical Devices; Radiology Devices; Classification of the Vaginal Hydrogel Packing System | record → |
| Sep 10, 2026 | Rule | Medical Devices; Gastroenterology-Urology Devices; Classification of the Implanted Tibial Electrical Urinary Continence Device | record → |
| Sep 10, 2026 | Rule | Medical Devices; Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT Surgery | record → |
| Sep 10, 2026 | Rule | Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Tumor Necrosis Factor Alpha Monoclonal Antib | record → |
| Sep 10, 2026 | Rule | Medical Devices; Cardiovascular Devices; Classification of the Extravascular Support for an Arteriovenous Fistula for Vascular Access | record → |
| Sep 10, 2026 | Rule | Medical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablati | record → |
| Sep 10, 2026 | Rule | Medical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation | record → |
| Sep 10, 2026 | Notice | Fee Rate for Using a Priority Review Voucher in Fiscal Year 2027 | record → |
| Sep 10, 2026 | Proposed Rule | Green Innovation GmbH; Withdrawal of Food Additive Petition (Animal Use) | record → |
| Sep 09, 2026 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; ANKTIVA | record → |
| Sep 09, 2026 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; ANZUPGO | record → |
| Sep 09, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of | record → |
| Sep 09, 2026 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEMBRY | record → |
| Sep 09, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products | record → |
| Sep 09, 2026 | Notice | Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-2027 | record → |
| Sep 09, 2026 | Notice | Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry; Availability | record → |
| Sep 04, 2026 | Notice | Advancing Development of Botanical Drug Products; Request for Information | record → |
| Sep 03, 2026 | Notice | Determination That PHENAPHEN WITH CODEINE NO. 3 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 30 Milligrams, and PHEN | record → |
| Sep 02, 2026 | Notice | International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate | record → |
| Sep 02, 2026 | Notice | International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate | record → |
| Sep 02, 2026 | Notice | Issuance of Priority Review Voucher; Rare Pediatric Disease Product; GENGLYCOS (parisglasgene brecaparvovec-opnr) | record → |
| Sep 02, 2026 | Notice | Dental Composite Resin Devices and Dental Curing Lights-Premarket Notification (510(k)) Submissions Guidances; Guidances for Industry and Fo | record → |
| Sep 02, 2026 | Notice | Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage; Draft Guidance for Industry; | record → |
| Sep 02, 2026 | Notice | Determination That CARAFATE (Sucralfate) Oral Suspension, 1 Gram/10 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effect | record → |
| Sep 01, 2026 | Notice | Determination That NAMENDA (Memantine Hydrochloride) Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Sa | record → |
| Aug 31, 2026 | Notice | Rahim Shafa; Denial of Hearing; Final Debarment Order | record → |
| Aug 31, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Removals and Corrections | record → |
| Aug 31, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilitie | record → |
| Aug 31, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Potential Tobacco Product | record → |
| Aug 31, 2026 | Notice | Authorization of Emergency Use for Three Animal Drugs for the Prevention and Treatment of New World Screwworm; Availability | record → |
| Aug 28, 2026 | Notice | Compounding Animal Drugs From Bulk Drug Substances: Compounding Under CGMP in Federally-Registered Facilities; Draft Guidance for Industry; | record → |
| Aug 28, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups and Interviews as Used by the Food and Drug Adm | record → |
| Aug 28, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, and | record → |
| Aug 28, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Associated With | record → |
| Aug 28, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Importation of Prescriptio | record → |
| Aug 28, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Qualitative Feedback on Agency Service Delivery | record → |
| Aug 27, 2026 | Notice | Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Second Extension of Effective Da | record → |
| Aug 26, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Allegations of Regulatory Misconduct Voluntarily Submitted t | record → |
| Aug 26, 2026 | Notice | International Drug Scheduling; Single Convention on Narcotic Drugs; Convention on Psychotropic Substances; Clobromazolam (Phenazolam); Cychl | record → |
| Aug 26, 2026 | Notice | Determination That CABAZITAXEL (Cabazitaxel) Solution (Injection), 60 Milligrams/6 Milliliters (10 Milligrams/Milliliter), Was Not Withdrawn | record → |
| Aug 24, 2026 | Notice | Evaluation of Therapeutic Equivalence; Guidance for Industry; Availability | record → |
| Aug 24, 2026 | Notice | Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability | record → |
| Aug 24, 2026 | Notice | Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 066 | record → |
| Aug 21, 2026 | Notice | Advisory Committee; Oncologic Drugs Advisory Committee; Renewal | record → |
| Aug 20, 2026 | Notice | Frequently Asked Questions-Developing Potential Cellular and Gene Therapy Products; Final Guidance for Industry; Availability | record → |
| Aug 20, 2026 | Notice | Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry; Availability | record → |
| Aug 20, 2026 | Notice | Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee; Renewal | record → |
| Aug 20, 2026 | Notice | Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee; Renewal | record → |
| Aug 19, 2026 | Proposed Rule | GNT USA, LLC.; Filing of Color Additive Petition | record → |
| Aug 19, 2026 | Rule | Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate | record → |
| Aug 19, 2026 | Proposed Rule | International Association of Color Manufacturers; Filing of Color Additive Petition | record → |
| Aug 19, 2026 | Proposed Rule | Gardenia Blue Interest Group; Filing of Color Additive Petition | record → |
| Aug 18, 2026 | Notice | Testosterone Use in Menopausal Women; Public Workshop; Request for Comments | record → |
| Aug 18, 2026 | Notice | Determining Whether To Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; Availability | record → |
| Aug 17, 2026 | Notice | Type VII Veterinary Master File for Research and Development and Risk Reviews; Guidance for Industry; Availability | record → |
| Aug 17, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Imports and Electronic Import Entries | record → |
| Aug 17, 2026 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; BIZENGRI | record → |
| Aug 17, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Re | record → |
| Aug 17, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements | record → |
| Aug 17, 2026 | Notice | Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals | record → |
| Aug 17, 2026 | Rule | Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Ther | record → |
| Aug 17, 2026 | Proposed Rule | Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended | record → |
| Aug 17, 2026 | Proposed Rule | Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for C | record → |
| Aug 14, 2026 | Notice | Container Closure Systems for Human Drugs and Biological Products; Draft Guidance for Industry; Availability | record → |
| Aug 14, 2026 | Notice | Determination That LASIX (Furosemide) Tablets, 20 Milligrams, 40 Milligrams, and 80 Milligrams, Were Not Withdrawn From Sale for Reasons of | record → |
| Aug 14, 2026 | Notice | Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments | record → |
| Aug 14, 2026 | Notice | Determination That ANSAID (Flurbiprofen) Tablets, 50 Milligrams and 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Ef | record → |
| Aug 13, 2026 | Notice | Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Guidance for | record → |
| Aug 13, 2026 | Notice | Kremers Urban Pharmaceuticals, Inc.; Grant of Hearing Request Regarding a Proposal To Withdraw Approval of an Abbreviated New Drug Applicati | record → |
| Aug 12, 2026 | Rule | Guide To Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce; Guidance for Industry; Availability | record → |
| Aug 11, 2026 | Proposed Rule | Substances Generally Recognized as Safe | record → |
| Aug 11, 2026 | Notice | Reauthorization of the Generic Drug User Fee Amendments; Public Meeting; Request for Comments | record → |
| Aug 10, 2026 | Proposed Rule | Radiology Devices; Reclassification of Digital Breast Tomosynthesis System | record → |
| Aug 10, 2026 | Notice | Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Reques | record → |
| Aug 10, 2026 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; DAYVIGO | record → |
| Aug 10, 2026 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; BRINSUPRI | record → |
| Aug 10, 2026 | Notice | Determination That OZOBAX (Baclofen) Oral Solution, 5 Milligrams/5 Milliliters Was Not Withdrawn From Sale for Reasons of Safety or Effectiv | record → |
| Aug 06, 2026 | Notice | Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to their Microbiological Effects on Bacteria of Human Health Concern; Gu | record → |
| Aug 06, 2026 | Rule | Medical Devices; Radiology Devices; Classification of the Fludeoxyglucose F18-Guided Radiation Therapy System | record → |
| Aug 06, 2026 | Notice | Authorization of Emergency Use of an In Vitro Diagnostic Device in Response to an Outbreak of Mpox; Availability | record → |
| Aug 05, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administrati | record → |
| Aug 05, 2026 | Notice | Establishment of a Quantitative Medicine Innovation Network: Scope, Feasibility, and Opportunities; Request for Information | record → |
| Aug 05, 2026 | Rule | Micro-Tracers, Inc.; Response to Objections and Requests for a Public Hearing | record → |
| Aug 03, 2026 | Notice | Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Revised Draft Guidance for Indus | record → |
| Aug 03, 2026 | Notice | Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs; Guidance for Industry; Availability | record → |
| Aug 03, 2026 | Notice | Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Draft Guidanc | record → |
| Aug 03, 2026 | Notice | Angela Anatilde Baquero: Final Debarment Order | record → |
| Aug 03, 2026 | Notice | Ricardo Andres Acuna: Final Debarment Order | record → |
| Aug 03, 2026 | Proposed Rule | Modification of Certain Terminology in Title 21; Reopening of the Comment Period | record → |
| Jul 30, 2026 | Notice | Prescription Drug User Fee Rates for Fiscal Year 2027 | record → |
| Jul 30, 2026 | Notice | Medical Device User Fee Rates for Fiscal Year 2027 | record → |
| Jul 30, 2026 | Notice | Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2027 | record → |
| Jul 30, 2026 | Notice | Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2027 | record → |
| Jul 30, 2026 | Notice | Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2027 | record → |
| Jul 30, 2026 | Notice | Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2027 | record → |
| Jul 30, 2026 | Notice | Outsourcing Facility Fee Rates for Fiscal Year 2027 | record → |
| Jul 30, 2026 | Notice | Generic Drug User Fee Rates for Fiscal Year 2027 | record → |
| Jul 30, 2026 | Notice | Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027 | record → |
| Jul 30, 2026 | Notice | Food Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2027 | record → |
| Jul 30, 2026 | Notice | Biosimilar User Fee Rates for Fiscal Year 2027 | record → |
| Jul 30, 2026 | Notice | Butylated Hydroxytoluene (BHT); Request for Information; Reopening of Comment Period | record → |
| Jul 29, 2026 | Notice | Product-Specific Guidances; Revised Draft Guidances for Industry; Availability | record → |
| Jul 29, 2026 | Notice | Statement of Organization, Functions, and Delegations of Authority | record → |
| Jul 29, 2026 | Rule | Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy | record → |
| Jul 28, 2026 | Notice | Fee Rate for Using a Priority Review Voucher in Fiscal Year 2026; Correction | record → |
| Jul 28, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Expanded Access to Investigational Drugs for Treatment Use | record → |
| Jul 28, 2026 | Notice | Pediatric Advisory Committee (PAC); Notice of Meeting; Establishment of a Public Docket; Request for Comments | record → |
| Jul 28, 2026 | Notice | Cancer Clinical Trial Eligibility Criteria: Performance Status; Guidance for Industry, Institutional Review Boards, and Clinical Investigato | record → |
| Jul 28, 2026 | Notice | Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Guidance for Industry, Institutional Review Boards, | record → |
| Jul 28, 2026 | Notice | Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Guidance for Industry, Institutional Review Boards, and Clinical Investigator | record → |
| Jul 27, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research | record → |
| Jul 27, 2026 | Rule | Medical Devices; Gastroenterology-Urology Devices; Classification of the Non-Medicated Topical Formulation for Treatment of Erectile Dysfunc | record → |
| Jul 27, 2026 | Rule | Medical Devices; General Hospital and Personal Use Devices; Classification of the Active Noise Attenuation System for Infant Incubators | record → |
| Jul 24, 2026 | Rule | Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Chronic Kidney | record → |
| Jul 24, 2026 | Rule | Medical Devices; Immunology and Microbiology Devices; Classification of the Over-the-Counter Test To Detect SARS-CoV-2 From Clinical Specime | record → |
| Jul 24, 2026 | Rule | Medical Devices; General Hospital and Personal Use Devices; Classification of the Diabetes Digital Behavioral Therapeutic Device | record → |
| Jul 24, 2026 | Rule | Medical Devices; Orthopedic Devices; Classification of the Intraoperative Surgical Angle Measurement Tool | record → |
| Jul 24, 2026 | Notice | Francis Esteban Matos: Final Debarment Order | record → |
| Jul 24, 2026 | Notice | Cellular, Tissue, and Gene Therapies Advisory Committee; Amendment of Notice-Biologics License Application (BLA) 125842 From Capricor, Inc. | record → |
| Jul 24, 2026 | Notice | Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologics | record → |
| Jul 24, 2026 | Proposed Rule | Evonik Corporation, Filing of Food Additive Petition (Animal Use) | record → |
| Jul 23, 2026 | Notice | Advisory Committee; Peripheral and Central Nervous System Drugs Advisory Committee; Termination and Reestablishment | record → |
| Jul 23, 2026 | Notice | FDA's Strategy Document on Facilitating Chemistry, Manufacturing, and Controls Readiness for Products With Accelerated Clinical Development | record → |
| Jul 23, 2026 | Proposed Rule | Proposal To Revoke the Color Additive Listing for Use of Citrus Red No. 2 on the Skins of Mature Oranges | record → |
| Jul 23, 2026 | Rule | Revocation of the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausages | record → |
| Jul 22, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notifications Su | record → |
| Jul 22, 2026 | Notice | Determination That RASUVO (Methotrexate) Solution, 27.5 Milligrams/0.55 Milliliter (27.5 Milligrams/0.55 Milliliter), Was Not Withdrawn From | record → |
| Jul 21, 2026 | Notice | Expedited Investigational New Drug Pilot Program; Request for Information; Extension of the Comment Period | record → |
| Jul 20, 2026 | Rule | Food Standards of Identity Modernization; Pasteurized Orange Juice | record → |
| Jul 17, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Cosmetic Products | record → |
| Jul 17, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary National Retail Food Regulatory Program Standards | record → |
| Jul 17, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Voluntary Improvement Program | record → |
| Jul 17, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements | record → |
| Jul 17, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Devices: (Medical Product | record → |
| Jul 17, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Accreditation Scheme for Conformity Assessment Program | record → |
| Jul 16, 2026 | Notice | Process for FDA Data Requests To Inform Certain Over-the-Counter Monograph Drug Activities; Procedure | record → |
| Jul 14, 2026 | Notice | Topical Dermatologic Corticosteroids: In Vivo Bioequivalence; Guidance for Industry; Availability | record → |
| Jul 14, 2026 | Notice | Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs | record → |
| Jul 14, 2026 | Notice | Considerations for Potential Future Therapeutic Use of Psychedelic Drugs; Public Hearing; Request for Comments | record → |
| Jul 14, 2026 | Notice | Psychedelic Drugs: Considerations for Clinical Investigations; Guidance for Industry; Availability | record → |
| Jul 13, 2026 | Proposed Rule | Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Es | record → |
| Jul 09, 2026 | Notice | Determination That TOVALT ODT (Zolpidem Tartrate) Orally Disintegrating Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sal | record → |
| Jul 08, 2026 | Notice | Medical Device User Fee Amendments; Public Meeting; Request for Comments | record → |
| Jul 08, 2026 | Notice | Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologics | record → |
| Jul 07, 2026 | Rule | New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor | record → |
| Jul 06, 2026 | Notice | Determination That VASOPRESSIN IN SODIUM CHLORIDE (vasopressin) 0.9%, Injection, 50 units/50 milliliters (1 unit/milliliters) Was Not Withdr | record → |
| Jul 06, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Approval of Medi | record → |
| Jul 06, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Biologics License Applications, Procedures and Requirements | record → |
| Jul 06, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Practices a | record → |
| Jul 06, 2026 | Notice | Expedited Investigational New Drug Pilot Program; Request for Information; Correction | record → |
| Jul 06, 2026 | Notice | Endo Operations Limited, et al.; Withdrawal of Approval of 34 New Drug Applications | record → |
| Jul 01, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medication Guides for Pres | record → |
| Jun 30, 2026 | Rule | Medical Devices; General and Plastic Surgery Devices; Classification of the Skin Patch for Treatment of Hyperhidrosis | record → |
| Jun 30, 2026 | Rule | Medical Devices; Anesthesiology Devices; Classification of the Monitor for Opioid Induced Impairment of Oxygenation | record → |
| Jun 29, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Minor | record → |
| Jun 29, 2026 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; VYALEV | record → |
| Jun 29, 2026 | Proposed Rule | Establishment Registration and Product Listing for Tobacco Products | record → |
| Jun 29, 2026 | Notice | Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologics | record → |
| Jun 29, 2026 | Rule | Medical Devices; Orthopedic Devices; Classification of the Medial Knee Implanted Shock Absorber | record → |
| Jun 26, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Time and Extent Applications for Nonprescription Drug Produc | record → |
| Jun 26, 2026 | Rule | Medical Devices; General Hospital and Personal Use Devices; Classification of the Foam or Gel Chemical Sterilant/High Level Disinfectant | record → |
| Jun 26, 2026 | Rule | Medical Devices; Clinical Chemistry and Toxicology Devices; Classification of the Prognostic Test for Development or Progression of Preeclam | record → |
| Jun 26, 2026 | Rule | Medical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for the Treatment of Fibromyalgia Sympto | record → |
| Jun 26, 2026 | Rule | Medical Devices; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test | record → |
| Jun 26, 2026 | Rule | Medical Devices; General and Plastic Surgery Devices; Classification of the Breast Implant Suction Retrieval System | record → |
| Jun 26, 2026 | Rule | Medical Devices; Neurological Devices; Classification of the External Lower Extremity Nerve Stimulator for Restless Legs Syndrome | record → |
| Jun 26, 2026 | Rule | Medical Devices; General Hospital and Personal Use Devices; Classification of the Infant Supine Sleep System | record → |
| Jun 26, 2026 | Notice | Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability | record → |
| Jun 26, 2026 | Notice | Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Extension of Effective Date of F | record → |
| Jun 26, 2026 | Notice | List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of | record → |
| Jun 26, 2026 | Notice | Determination That RECTIV (Nitroglycerin) Ointment, 0.4%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | record → |
| Jun 26, 2026 | Notice | Determination That Prednisolone Tablet, 5 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | record → |
| Jun 25, 2026 | Proposed Rule | Sterigenics U.S., LLC; Filing of Food Additive Petition | record → |
| Jun 24, 2026 | Notice | Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) | record → |
| Jun 24, 2026 | Notice | Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Availability | record → |
| Jun 24, 2026 | Notice | Expedited Investigational New Drug Pilot Program; Request for Information | record → |
| Jun 24, 2026 | Notice | Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Revised Draft Guidance for Industry; Availabilit | record → |
| Jun 24, 2026 | Notice | International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Ant | record → |
| Jun 24, 2026 | Notice | International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Ant | record → |
| Jun 24, 2026 | Notice | International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Ant | record → |
| Jun 24, 2026 | Notice | International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Ant | record → |
| Jun 24, 2026 | Notice | International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Ant | record → |
| Jun 24, 2026 | Notice | International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Ant | record → |
| Jun 24, 2026 | Notice | International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Ant | record → |
| Jun 24, 2026 | Notice | International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Ant | record → |
| Jun 24, 2026 | Notice | International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Ant | record → |
| Jun 23, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Potential Tobacco Product Violations Reporting Form | record → |
| Jun 23, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification of Identity, | record → |
| Jun 22, 2026 | Notice | Epizyme, Inc.; Withdrawal of Approval of New Drug Application for TAZVERIK (Tazemetostat) Tablet, 200 Milligrams | record → |
| Jun 22, 2026 | Rule | Medical Devices; Immunology and Microbiology Devices; Classification of the Simple In Vitro Diagnostic Device for the Detection of Secreted | record → |
| Jun 22, 2026 | Rule | Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Light-Projecting Measuring Device | record → |
| Jun 22, 2026 | Rule | Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Traction Device | record → |
| Jun 18, 2026 | Notice | Advisory Committee; Science Board to the Food and Drug Administration; Renewal | record → |
| Jun 18, 2026 | Notice | SpecGx LLC; Withdrawal of Approval of Abbreviated New Drug Application for Methylphenidate Hydrochloride Extended-Release Tablets, 27 Millig | record → |
| Jun 18, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing | record → |
| Jun 18, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing | record → |
| Jun 18, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals | record → |
| Jun 18, 2026 | Notice | Authorization of Emergency Use for Two Animal Drugs for the Prevention and Treatment of New World Screwworm; Availability | record → |
| Jun 17, 2026 | Rule | Medical Devices; Gastroenterology-Urology Devices; Classification of the Ingestible Gastrointestinal Blood Detection Capsule | record → |
| Jun 17, 2026 | Rule | Medical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermin | record → |
| Jun 17, 2026 | Notice | Andrew Jonathan Morgan: Final Debarment Order | record → |
| Jun 16, 2026 | Notice | Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, et al.; Withdrawal of Approval of 11 Abbreviated New Drug Applications; Correction | record → |
| Jun 15, 2026 | Notice | Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability | record → |
| Jun 15, 2026 | Rule | Amendment and Revocation of Organizational Information Regulations | record → |
| Jun 11, 2026 | Notice | Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments; Reopening of the Comment Period | record → |
| Jun 11, 2026 | Notice | Drug Repurposing for Unmet Medical Needs; Request for Information; Extension of Comment Period | record → |
| Jun 11, 2026 | Rule | Medical Devices; Immunology and Microbiology Devices; Classification of the Simple Point-of-Care Device to Directly Detect SARS-CoV-2 Viral | record → |
| Jun 11, 2026 | Rule | Medical Devices; Immunology and Microbiology Devices; Classification of the Spinal Muscular Atrophy Newborn Screening Test System | record → |
| Jun 11, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment, Maintenance | record → |
| Jun 11, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Procedures for the Safe Pr | record → |
| Jun 10, 2026 | Notice | Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information | record → |
| Jun 10, 2026 | Rule | Medical Devices; Ear, Nose, and Throat Devices; Classification of the Combined Acoustic and Electrical External Stimulation Device for the R | record → |
| Jun 08, 2026 | Notice | Determination That Protamine Sulfate (Protamine Sulfate) Intravenous; Solution, 50 Milligrams/5 Milliliters, and Other Drug Products Were No | record → |
| Jun 05, 2026 | Rule | Medical Devices; Orthopedic Devices; Classification of the Absorbable Metallic Bone Fixation Fastener | record → |
| Jun 05, 2026 | Notice | Intent To Exempt Certain Unclassified Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Admi | record → |
| Jun 05, 2026 | Rule | Medical Devices; Orthopedic Devices; Classification of the Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented or Unc | record → |
| Jun 05, 2026 | Rule | Medical Devices; Orthopedic Devices; Classification of the Resorbable Calcium Salt Bone Void Filler Containing a Single Approved Aminoglycos | record → |
| Jun 03, 2026 | Notice | Vanda Pharmaceuticals, Inc.; Grant of Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETL | record → |
| Jun 03, 2026 | Notice | Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry; Avai | record → |
| Jun 03, 2026 | Notice | Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Gui | record → |
| Jun 03, 2026 | Notice | Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications | record → |
| Jun 03, 2026 | Notice | Third Annual Animal Drug User Fee Educational Conference; Public Meeting | record → |
| Jun 03, 2026 | Rule | New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Chang | record → |
| Jun 03, 2026 | Notice | M15 General Principles for Model-Informed Drug Development; International Council for Harmonisation; Guidance for Industry; Availability | record → |
| Jun 01, 2026 | Notice | Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availab | record → |
| Jun 01, 2026 | Rule | Medical Devices; Ear, Nose, and Throat Devices; Classification of the Oropharyngeal Electrical Stimulator | record → |
| Jun 01, 2026 | Rule | Medical Devices; Hematology and Pathology Devices; Classification of the Von Willebrand Factor Assay | record → |
| Jun 01, 2026 | Rule | Medical Devices; Dental Devices; Classification of the Intraoral Cooling Device | record → |
| Jun 01, 2026 | Rule | Medical Devices; Gastroenterology-Urology Devices; Classification of the Orally Ingested Transient Device for Constipation | record → |
| Jun 01, 2026 | Rule | Medical Devices; Anesthesiology Devices; Classification of the Adjunctive Pain Measurement Device for Anesthesiology | record → |
| Jun 01, 2026 | Rule | Medical Devices; Anesthesiology Devices; Classification of the Real-Time Ultrasound Anatomy Visualization and Labeling Device for Ultrasound | record → |
| Jun 01, 2026 | Rule | Medical Devices; General Hospital and Personal Use Devices; Classification of the Rigid Sterilization Container With Electronic Monitoring | record → |
| May 29, 2026 | Notice | Advisory Committee; Psychopharmacologic Drugs Advisory Committee; Renewal | record → |
| May 29, 2026 | Rule | Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms | record → |
| May 29, 2026 | Notice | Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Guidance for Industry; | record → |
| May 29, 2026 | Notice | Statistical Approaches To Establishing Bioequivalence; Guidance for Industry; Availability | record → |
| May 29, 2026 | Notice | Content of Human Factors Information in Medical Device Marketing Submissions; Guidance for Industry and Food and Drug Administration Staff; | record → |
| May 29, 2026 | Notice | Patient-Focused Drug Development for Nonhealing Chronic Wounds; Public Meeting; Request for Comments | record → |
| May 28, 2026 | Notice | AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information; Extension of Comment Period | record → |
| May 28, 2026 | Notice | Challenges and Solutions in Lot-Level Food Traceability; Public Meeting and Request for Comments | record → |
| May 28, 2026 | Proposed Rule | Color Additive Petition from Environmental Defense Fund, et al.; Request To Amend the Color Additive Regulations To Remove the Solvents Ethy | record → |
| May 28, 2026 | Proposed Rule | Food Additive Petition From Environmental Defense Fund, et al.; Request To Amend the Food Additive Regulations To Remove the Solvents Benzen | record → |
| May 28, 2026 | Rule | Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Suturing Device for Altering Gastric Anatomy for Weight | record → |
| May 27, 2026 | Notice | Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Syntest D.S. and Syntest H.S. Ta | record → |
| May 26, 2026 | Notice | Advisory Committee; Drug Safety and Risk Management Advisory Committee; Renewal | record → |
| May 26, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the F | record → |
| May 26, 2026 | Notice | Advisory Committee; Pulmonary-Allergy Drugs Advisory Committee; Renewal | record → |
| May 22, 2026 | Notice | Notice of Decision Not To Designate Hepatitis Delta Virus Diseases as an Addition to the Current List of Tropical Diseases in the Federal Fo | record → |
| May 22, 2026 | Notice | Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability | record → |
| May 22, 2026 | Notice | Protein Efficiency Ratio Rat Bioassay Studies To Demonstrate That a New Infant Formula Supports the Quality Factor of Sufficient Biological | record → |
| May 22, 2026 | Notice | M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP); International Council for Harmonisation; Guidance for Industry; Availabili | record → |
| May 22, 2026 | Notice | Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Safet | record → |
| May 21, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Required Warnings for Ciga | record → |
| May 21, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing | record → |
| May 21, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience/Events | record → |
| May 21, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Patent Term Restoration; D | record → |
| May 15, 2026 | Notice | Oscar Bobo: Final Debarment Order | record → |
| May 13, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; The Real Cost Campaign Out | record → |
| May 13, 2026 | Notice | Butylated Hydroxytoluene (BHT); Request for Information | record → |
| May 13, 2026 | Notice | Azodicarbonamide (ADA); Request for Information | record → |
| May 13, 2026 | Notice | Biomarker Incubator: Urinary Kidney Safety Biomarkers; Request for Information | record → |
| May 13, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting | record → |
| May 13, 2026 | Notice | Modified Risk Tobacco Product Application: Renewal Applications for VLN® King and VLN® Menthol King, Cigarette Products Submitted by 22nd Ce | record → |
| May 12, 2026 | Rule | Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microorganism Nucleic Acids and Re | record → |
| May 12, 2026 | Notice | Drug Repurposing for Unmet Medical Needs; Request for Information | record → |
| May 12, 2026 | Notice | Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization; Guidance for Industry; Availability | record → |
| May 12, 2026 | Notice | 21st Century Cures Act: Annual Compilation of Notices of Updates From the Susceptibility Test Interpretive Criteria web page | record → |
| May 11, 2026 | Notice | Issuance of Priority Review Voucher; Rare Pediatric Disease Product; AVLAYAH (tividenofusp alfa-eknm) | record → |
| May 11, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications On | record → |
| May 11, 2026 | Notice | Clostridioides Difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, or Prevention; Guidance for Industry; Availabil | record → |
| May 11, 2026 | Notice | Postapproval Pregnancy Safety Studies; Guidance for Industry; Availability | record → |
| May 11, 2026 | Notice | Pulmonary Tuberculosis: Developing Drugs for Treatment; Guidance for Industry; Availability | record → |
| May 11, 2026 | Notice | Animal Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Drug User Fee Act Reauthorization; Request for Notification of Sta | record → |
| May 11, 2026 | Notice | Animal Generic Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Generic Drug User Fee Act Reauthorization; Request for Not | record → |
| May 08, 2026 | Rule | Medical Devices; Obstetrical and Gynecological Devices; Classification of the External Condom for Anal Intercourse or Vaginal Intercourse | record → |
| May 08, 2026 | Notice | Determination That Leucovorin Calcium, Oral Solution, Equivalent to 60 Milligrams Base/Vial, Was Not Withdrawn From Sale for Reasons of Safe | record → |
| May 07, 2026 | Notice | Determination That MICARDIS (Telmisartan), Tablets, 20 Milligrams and 80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or E | record → |
| May 07, 2026 | Notice | Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications | record → |
| May 07, 2026 | Notice | Patient-Matched Guides for Orthopedic Implants; Guidance for Industry and Food and Drug Administration Staff; Availability | record → |
| May 07, 2026 | Notice | Advisory Committee; Blood Products Advisory Committee; Renewal | record → |
| May 06, 2026 | Rule | Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Preserve and Stabilize Relative Abundances of Microbia | record → |
| May 06, 2026 | Rule | Medical Devices; Immunology and Microbiology Devices; Classification of the Circulating Tumor Cell Enrichment Device | record → |
| May 06, 2026 | Rule | Medical Devices; Ophthalmic Devices; Classification of the Corneal Storage Medium With Preservatives Including Antifungals | record → |
| May 06, 2026 | Proposed Rule | Modification of Certain Terminology in Title 21 | record → |
| May 06, 2026 | Notice | Issuance of Priority Review Voucher; Rare Pediatric Disease Product; OTARMENI (lunsotogene parvec-cwha) | record → |
| May 06, 2026 | Notice | Determination That DEXAMETHASONE (Dexamethasone) Elixir, 0.5 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or | record → |
| May 04, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; National Youth Tobacco Survey | record → |
| May 01, 2026 | Rule | Medical Devices; General and Plastic Surgery Devices; Classification of the Phototherapy Device for Reducing the Appearance of Acute Post-Su | record → |
| May 01, 2026 | Notice | Medical Devices; Exemptions From Premarket Notification: Certain Class II Devices; Request for Comments | record → |
| May 01, 2026 | Notice | Obesity and Drug Dosing: Clinical Pharmacology Considerations; Request for Comments | record → |
| May 01, 2026 | Notice | Impacts of Patient-Focused Drug Development Meetings; Establishment of a Public Docket; Request for Information and Comments | record → |
| May 01, 2026 | Notice | List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act | record → |
| Apr 30, 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Requirements for Nonclinical Labora | record → |
| Apr 30, 2026 | Notice | Advisory Committee; Pharmacy Compounding Advisory Committee; Renewal | record → |
| Apr 30, 2026 | Notice | Determination FENOGLIDE (Fenofibrate) Tablets, 40 Milligrams and 120 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effect | record → |
| Apr 30, 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Hazard Analysis and Critic | record → |
| Apr 30, 2026 | Rule | Medical Devices; Radiology Devices; Classification of the Radiation Therapy Marking Device | record → |
| Apr 30, 2026 | Rule | Medical Devices; Neurological Devices; Classification of the Brain Temperature Measurement System | record → |
| Apr 30, 2026 | Rule | Medical Devices; Cardiovascular Devices; Classification of the Laser-Powered Inferior Vena Cava Filter Retrieval Catheter | record → |
| Apr 30, 2026 | Notice | Determination That OZEMPIC (Semaglutide) Solution, 2 Milligrams Per 1.5 Milliliters Was Not Withdrawn From Sale for Reasons of Safety or Eff | record → |
| Apr 30, 2026 | Notice | ChemoCentryx, Inc.; Proposal To Withdraw Approval of New Drug Application for TAVNEOS (Avacopan) Capsule, 10 Milligrams; Opportunity for a H | record → |
| Apr 29, 2026 | Notice | AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information | record → |
| Apr 27, 2026 | Notice | Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Unite | record → |
| Apr 27, 2026 | Notice | Advisory Committee; Anesthetic and Analgesic Drug Products Advisory Committee; Renewal | record → |
| Apr 24, 2026 | Notice | Egis Pharmaceuticals Limited, et al.; Withdrawal of Approval of Three Abbreviated New Drug Applications | record → |
| Apr 24, 2026 | Notice | Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability | record → |
| Apr 23, 2026 | Notice | Kimberly Schaff Kiehl: Final Debarment Order | record → |
| Apr 23, 2026 | Notice | Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke; Established List Additions and Request for Comments | record → |
| Apr 23, 2026 | Notice | Commissioner's National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for Comments; Amendment | record → |
| Apr 22, 2026 | Rule | Medical Devices; Immunology and Microbiology Devices; Classification of the Alzheimer's Disease Pathology Assessment Test | record → |
| Apr 22, 2026 | Rule | Medical Devices; Ophthalmic Devices; Classification of the Digital Therapy Device for Amblyopia | record → |
| Apr 22, 2026 | Rule | Medical Devices; Anesthesiology Devices; Classification of the Device for Sleep Apnea Testing Based on Mandibular Movement | record → |
| Apr 22, 2026 | Rule | Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Setmelanotide Eligibility Gene Variant Detection | record → |
| Apr 20, 2026 | Notice | Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators; Draft Guidance for Indust | record → |