| Electronic Common Technical Document (eCTD); Data Standards; Supporting Forward Compatibility for eCTD 4.0 |
Notice |
2026-10-16 |
Health and Human Services Department, Food and Drug Administration |
| Electronic Common Technical Document; Data Standards; Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Supporting Electronic Common Technical Document Version 3.2.2 and Version 4.0 |
Notice |
2026-10-16 |
Health and Human Services Department, Food and Drug Administration |
| Fit-for-Purpose Rare Disease Framework Initiative; Public Meeting; Request for Information and Comments |
Notice |
2026-10-16 |
Health and Human Services Department, Food and Drug Administration |
| Authorization of Emergency Use for Four Animal Drugs for the Prevention and Treatment of New World Screwworm; Availability |
Notice |
2026-10-15 |
Health and Human Services Department, Food and Drug Administration |
| Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products Scientific Advisory Committee (TPSAC) |
Notice |
2026-10-15 |
Health and Human Services Department, Food and Drug Administration |
| Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Cosmetic Products |
Notice |
2026-10-14 |
Health and Human Services Department, Food and Drug Administration |
| Advisory Committee; Cellular, Tissue, and Gene Therapies Advisory Committee; Renewal |
Notice |
2026-10-14 |
Health and Human Services Department, Food and Drug Administration |
| Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail Food Regulatory Program Standards |
Notice |
2026-10-14 |
Health and Human Services Department, Food and Drug Administration |
| Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Requirements |
Notice |
2026-10-14 |
Health and Human Services Department, Food and Drug Administration |
| Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate |
Rule |
2026-10-14 |
Health and Human Services Department, Food and Drug Administration |
| Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods |
Rule |
2026-10-13 |
Health and Human Services Department, Food and Drug Administration |
| Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Availability |
Notice |
2026-10-13 |
Health and Human Services Department, Food and Drug Administration |
| Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ZANVASTRO (Zilganersen) |
Notice |
2026-10-09 |
Health and Human Services Department, Food and Drug Administration |
| Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biologics License Applications, Procedures and Requirements |
Notice |
2026-10-09 |
Health and Human Services Department, Food and Drug Administration |
| Determination of Regulatory Review Period for Purposes of Patent Extension; MONOFERRIC |
Notice |
2026-10-09 |
Health and Human Services Department, Food and Drug Administration |
| Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expanded Access to Investigational Drugs for Treatment Use |
Notice |
2026-10-09 |
Health and Human Services Department, Food and Drug Administration |
| Determination That LASIX (Furosemide) Oral Solution, 10 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness |
Notice |
2026-10-09 |
Health and Human Services Department, Food and Drug Administration |
| Par Health USA LLC, U.S. Agent for PH Health Limited, et al.; Withdrawal of Approval of 37 Abbreviated New Drug Applications |
Notice |
2026-10-09 |
Health and Human Services Department, Food and Drug Administration |
| Amneal Pharmaceuticals of New York, LLC; Withdrawal of Approval of Abbreviated New Drug Application for Celecoxib Capsules, 50 Milligrams, 100 Milligrams, 200 Milligrams, and 400 Milligrams |
Notice |
2026-10-09 |
Health and Human Services Department, Food and Drug Administration |
| Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction |
Notice |
2026-10-09 |
Health and Human Services Department, Food and Drug Administration |
| Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected Specimens |
Rule |
2026-10-09 |
Health and Human Services Department, Food and Drug Administration |
| Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use |
Rule |
2026-10-09 |
Health and Human Services Department, Food and Drug Administration |
| Medical Devices; Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment Kit |
Rule |
2026-10-09 |
Health and Human Services Department, Food and Drug Administration |
| Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants; Draft Guidance for Industry; Availability |
Proposed Rule |
2026-10-09 |
Health and Human Services Department, Food and Drug Administration |
| Challenges and Solutions in Lot-Level Food Traceability; Public Meeting |
Notice |
2026-10-09 |
Health and Human Services Department, Food and Drug Administration |