id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
FDA-2023-N-0119-0020,FDA,FDA-2023-N-0119,"Fiscal Year 2026 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for
Comments",Notice,Request for Comments,2026-02-27T05:00:00Z,2026,2,2026-02-27T05:00:00Z,2026-07-11T03:59:59Z,2026-02-27T19:57:39Z,2026-03961,1,0,09000064b91e326c
FDA-2007-D-0369-2428,FDA,FDA-2007-D-0369,Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability,Notice,Notice of Availability,2026-02-27T05:00:00Z,2026,2,2026-02-27T05:00:00Z,,2026-02-27T19:14:17Z,2026-03963,0,0,09000064b91e3271
FDA-1991-N-0191-0010,FDA,FDA-1991-N-0191,"Civil Money Penalties; Biologics, Drugs, and Medical Devices; Extension of Comment Period; Correction and Addition
Period; Correction and Addition",Notice,Notice of Extension,2026-02-27T05:00:00Z,2026,2,2026-02-27T05:00:00Z,1993-08-26T03:59:59Z,2026-02-28T02:00:09Z,93-17833,0,0,090000648052deaf
FDA-2026-N-1486-0001,FDA,FDA-2026-N-1486,Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ZYCUBO (Copper Histidinate),Notice,Announcement,2026-02-27T05:00:00Z,2026,2,2026-02-27T05:00:00Z,,2026-02-27T20:11:11Z,2026-03925,0,0,09000064b91e323b
FDA-2026-N-1628-0001,FDA,FDA-2026-N-1628,International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Scheduling Recommendations; N-Pyrrolidino Isotonitazene; N-Desethyl Etonitazene; Coca Leaf; MDMB-FUBINACA; Request for Comments,Notice,Request for Comments,2026-02-27T05:00:00Z,2026,2,2026-02-27T05:00:00Z,2026-03-06T04:59:59Z,2026-02-27T20:18:13Z,2026-03914,1,0,09000064b91e31af
FDA-2024-E-3572-0007,FDA,FDA-2024-E-3572,Determination of Regulatory Review Period for Purposes of Patent Extension; TEVIMBRA,Notice,Determinations,2026-02-26T05:00:00Z,2026,2,2026-02-26T05:00:00Z,2026-04-28T03:59:59Z,2026-02-26T20:52:55Z,2026-03851,1,0,09000064b91deb48
FDA-2025-E-0161-0006,FDA,FDA-2025-E-0161,Determination of Regulatory Review Period for Purposes of Patent Extension; ORLYNVAH,Notice,Determinations,2026-02-26T05:00:00Z,2026,2,2026-02-26T05:00:00Z,2026-04-28T03:59:59Z,2026-02-26T20:55:38Z,2026-03848,1,0,09000064b91deb09
FDA-2024-E-3565-0006,FDA,FDA-2024-E-3565,Determination of Regulatory Review Period for Purposes of Patent Extension; LIMFLOW SYSTEM,Notice,Determinations,2026-02-26T05:00:00Z,2026,2,2026-02-26T05:00:00Z,2026-04-28T03:59:59Z,2026-02-26T20:38:14Z,2026-03855,1,0,09000064b91e03ee
FDA-2024-E-3555-0007,FDA,FDA-2024-E-3555,Determination of Regulatory Review Period for Purposes of Patent Extension; LIMFLOW SYSTEM,Notice,Determinations,2026-02-26T05:00:00Z,2026,2,2026-02-26T05:00:00Z,2026-04-28T03:59:59Z,2026-02-26T20:35:08Z,2026-03855,1,0,09000064b91dec48
FDA-2025-N-2549-0004,FDA,FDA-2025-N-2549,Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records,Notice,30 Day Proposed Information Collection,2026-02-26T05:00:00Z,2026,2,2026-02-26T05:00:00Z,2026-03-31T03:59:59Z,2026-02-26T20:50:21Z,2026-03857,1,0,09000064b91dec05
FDA-2025-E-1226-0007,FDA,FDA-2025-E-1226,Determination of Regulatory Review Period for Purposes of Patent Extension; AEROPACE,Notice,Determinations,2026-02-26T05:00:00Z,2026,2,2026-02-26T05:00:00Z,2026-04-28T03:59:59Z,2026-02-26T20:32:36Z,2026-03849,1,0,09000064b91dec81
FDA-2025-E-1229-0006,FDA,FDA-2025-E-1229,Determination of Regulatory Review Period for Purposes of Patent Extension; MERIT MEDICAL WRAPSODY,Notice,Determinations,2026-02-26T05:00:00Z,2026,2,2026-02-26T05:00:00Z,2026-04-28T03:59:59Z,2026-02-26T20:43:12Z,2026-03853,1,0,09000064b91e03f1
FDA-2025-E-0371-0006,FDA,FDA-2025-E-0371,Determination of Regulatory Review Period for Purposes of Patent Extension; REVUFORJ,Notice,Determinations,2026-02-26T05:00:00Z,2026,2,2026-02-26T05:00:00Z,2026-04-28T03:59:59Z,2026-02-26T20:46:51Z,2026-03847,1,0,09000064b91dec08
FDA-2024-E-3564-0006,FDA,FDA-2024-E-3564,Determination of Regulatory Review Period for Purposes of Patent Extension; LIMFLOW SYSTEM,Notice,Determinations,2026-02-26T05:00:00Z,2026,2,2026-02-26T05:00:00Z,2026-04-28T03:59:59Z,2026-02-26T20:36:56Z,2026-03855,1,0,09000064b91e03ed
FDA-2025-E-0500-0006,FDA,FDA-2025-E-0500,Determination of Regulatory Review Period for Purposes of Patent Extension; TRYNGOLZA,Notice,Determinations,2026-02-26T05:00:00Z,2026,2,2026-02-26T05:00:00Z,2026-04-28T03:59:59Z,2026-02-26T20:57:25Z,2026-03850,1,0,09000064b91deac5
FDA-2025-E-1228-0006,FDA,FDA-2025-E-1228,Determination of Regulatory Review Period for Purposes of Patent Extension; MERIT MEDICAL WRAPSODY,Notice,Determinations,2026-02-26T05:00:00Z,2026,2,2026-02-26T05:00:00Z,2026-04-28T03:59:59Z,2026-02-27T10:00:26Z,2026-03853,1,0,09000064b91dec45
FDA-2025-N-0195-0003,FDA,FDA-2025-N-0195,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2026-02-25T05:00:00Z,2026,2,2026-02-25T05:00:00Z,,2026-02-25T18:43:32Z,2026-03774,0,0,09000064b91da9f5
FDA-2011-N-0179-0041,FDA,FDA-2011-N-0179,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2026-02-25T05:00:00Z,2026,2,2026-02-25T05:00:00Z,,2026-02-25T18:54:39Z,2026-03774,0,0,09000064b91da06e
FDA-2025-N-0339-0005,FDA,FDA-2025-N-0339,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2026-02-25T05:00:00Z,2026,2,2026-02-25T05:00:00Z,,2026-02-25T18:48:04Z,2026-03774,0,0,09000064b91da190
FDA-2010-D-0350-0035,FDA,FDA-2010-D-0350,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Retailer Training Programs,Notice,30 Day Proposed Information Collection,2026-02-25T05:00:00Z,2026,2,2026-02-25T05:00:00Z,2026-03-28T03:59:59Z,2026-02-25T21:05:09Z,2026-03771,1,0,09000064b91d5d25
FDA-2024-N-5579-0004,FDA,FDA-2024-N-5579,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2026-02-25T05:00:00Z,2026,2,2026-02-25T05:00:00Z,,2026-02-25T18:45:07Z,2026-03774,0,0,09000064b91daa30
FDA-2025-N-0734-0004,FDA,FDA-2025-N-0734,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2026-02-25T05:00:00Z,2026,2,2026-02-25T05:00:00Z,,2026-02-25T18:41:54Z,2026-03774,0,0,09000064b91da9f4
FDA-2025-N-0418-0006,FDA,FDA-2025-N-0418,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2026-02-25T05:00:00Z,2026,2,2026-02-25T05:00:00Z,,2026-02-25T18:49:26Z,2026-03774,0,0,09000064b91da191
FDA-2026-D-1256-0001,FDA,FDA-2026-D-1256,Considerations for the Use of the Plausible Mechanism Framework To Develop Individualized Therapies That Target Specific Genetic Conditions With Known Biological Cause; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2026-02-25T05:00:00Z,2026,2,2026-02-25T05:00:00Z,,2026-02-25T19:04:38Z,2026-03713,0,0,09000064b91da53f
FDA-2026-N-0027-0001,FDA,FDA-2026-N-0027,"Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing",Notice,60 Day Proposed Information Collection,2026-02-25T05:00:00Z,2026,2,2026-02-25T05:00:00Z,2026-04-28T03:59:59Z,2026-02-25T19:16:33Z,2026-03773,1,0,09000064b91da53a
FDA-2025-N-0373-0005,FDA,FDA-2025-N-0373,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2026-02-25T05:00:00Z,2026,2,2026-02-25T05:00:00Z,,2026-02-25T18:38:37Z,2026-03774,0,0,09000064b91da9f3
FDA-2025-N-0706-0004,FDA,FDA-2025-N-0706,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2026-02-25T05:00:00Z,2026,2,2026-02-25T05:00:00Z,,2026-02-25T18:35:42Z,2026-03774,0,0,09000064b91da698
FDA-2024-N-5944-0005,FDA,FDA-2024-N-5944,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2026-02-25T05:00:00Z,2026,2,2026-02-25T05:00:00Z,,2026-02-25T18:46:30Z,2026-03774,0,0,09000064b91da18f
FDA-2026-N-0496-0001,FDA,FDA-2026-N-0496,Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds,Notice,60 Day Proposed Information Collection,2026-02-25T05:00:00Z,2026,2,2026-02-25T05:00:00Z,2026-04-28T03:59:59Z,2026-02-25T18:59:39Z,2026-03772,1,0,09000064b91da591
FDA-2026-N-0686-0001,FDA,FDA-2026-N-0686,"Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements",Notice,60 Day Proposed Information Collection,2026-02-24T05:00:00Z,2026,2,2026-02-24T05:00:00Z,2026-04-28T03:59:59Z,2026-02-24T19:45:30Z,2026-03589,1,0,09000064b91d5809
FDA-2026-N-0008-0001,FDA,FDA-2026-N-0008,Advisory Committee; Gastrointestinal Drugs Advisory Committee; Renewal,Notice,Notice of Renewal,2026-02-24T05:00:00Z,2026,2,2026-02-24T05:00:00Z,,2026-02-24T20:00:59Z,2026-03587,0,0,09000064b91d5691
FDA-2025-N-4348-0007,FDA,FDA-2025-N-4348,"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act",Notice,30 Day Proposed Information Collection,2026-02-23T05:00:00Z,2026,2,2026-02-23T05:00:00Z,2026-03-26T03:59:59Z,2026-02-23T19:24:04Z,2026-03448,1,0,09000064b91d0371
FDA-2025-P-1808-0004,FDA,FDA-2025-P-1808,"Determination That Klonopin (Clonazepam) Tablets, 0.125 Milligrams and 0.25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness",Notice,Determinations,2026-02-23T05:00:00Z,2026,2,,,2026-02-23T19:17:58Z,2026-03495,0,0,09000064b91d0373
FDA-2026-N-0672-0001,FDA,FDA-2026-N-0672,Issuance of Priority Review Voucher; Rare Pediatric Disease Product; WASKYRA (etuvetidigene autotemcel),Notice,Announcement,2026-02-23T05:00:00Z,2026,2,,,2026-02-23T19:28:45Z,2026-03493,0,0,09000064b91d029d
FDA-2024-N-1939-0023,FDA,FDA-2024-N-1939,"Requirements for Additional Traceability Records for Certain Foods; Exemption for Cottage Cheese
Regulated by the National Conference on Interstate Milk Shipments Grade ‘‘A’’ Pasteurized Milk Ordinance",Notice,Announcement,2026-02-20T05:00:00Z,2026,2,2026-02-20T05:00:00Z,,2026-02-20T19:57:25Z,2026-03362,0,0,09000064b91c75b3
FDA-2026-N-0746-0001,FDA,FDA-2026-N-0746,"Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for
Finished Pharmaceuticals (Including Active Pharmaceutical Ingredients) and the Advanced Manufacturing
Technologies Designation Program",Notice,60 Day Proposed Information Collection,2026-02-20T05:00:00Z,2026,2,2026-02-20T05:00:00Z,2026-04-22T03:59:59Z,2026-02-21T10:00:24Z,2026-03326,1,0,09000064b91c75af
FDA-2026-N-1224-0001,FDA,FDA-2026-N-1224,"Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, et al.; Withdrawal of Approval of 11 Abbreviated New Drug Applications",Notice,Withdrawal,2026-02-20T05:00:00Z,2026,2,2026-02-20T05:00:00Z,,2026-02-20T20:33:28Z,2026-03411,0,0,09000064b91c30c7
FDA-2026-N-1305-0001,FDA,FDA-2026-N-1305,Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Minor Use and Minor Species,Notice,60 Day Proposed Information Collection,2026-02-20T05:00:00Z,2026,2,2026-02-20T05:00:00Z,2026-04-22T03:59:59Z,2026-02-20T20:30:11Z,2026-03353,1,0,09000064b91c750d
FDA-2025-D-2837-0001,FDA,FDA-2025-D-2837,Questions and Answers About Requirements for Additional Traceability Records for Certain Foods; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2026-02-20T05:00:00Z,2026,2,2026-02-20T05:00:00Z,,2026-02-20T20:36:36Z,2026-03363,0,0,09000064b91c3081
FDA-2026-N-0499-0001,FDA,FDA-2026-N-0499,Agency Information Collection Activities; Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice,Notice,60 Day Proposed Information Collection,2026-02-20T05:00:00Z,2026,2,2026-02-20T05:00:00Z,2026-04-22T03:59:59Z,2026-02-20T20:23:05Z,2026-03332,1,0,09000064b91c75b1
FDA-2026-N-0684-0001,FDA,FDA-2026-N-0684,Agency Information Collection Activities; Proposed Collection; Comment Request; Approved Organizations for Wholesale Drug Distributors and Third-Party Logistics Providers,Notice,60 Day Proposed Information Collection,2026-02-20T05:00:00Z,2026,2,2026-02-20T05:00:00Z,2026-04-22T03:59:59Z,2026-02-20T20:51:55Z,2026-03333,1,0,09000064b91c307f
FDA-2025-N-1927-0102,FDA,FDA-2025-N-1927,GRAS Notice (GRN) 1220 - Mycelial biomass from Pleurotus pulmonarius – amendments,Notice,General Notice,2026-02-19T05:00:00Z,2026,2,2026-02-19T05:00:00Z,,2026-02-19T18:41:53Z,,0,0,09000064b91b9273
FDA-2025-N-1928-0048,FDA,FDA-2025-N-1928,GRAS Notice (GRN) 1260 - Rebaudioside M - amendments,Notice,General Notice,2026-02-19T05:00:00Z,2026,2,2026-02-19T05:00:00Z,,2026-02-19T18:44:51Z,,0,0,09000064b91b93bd
FDA-2025-N-1928-0051,FDA,FDA-2025-N-1928,GRAS Notice (GRN) 1284 - Recombinant bovine lactoferrin produced by a modified strain of Komagataella phaffii,Notice,General Notice,2026-02-19T05:00:00Z,2026,2,2026-02-19T05:00:00Z,,2026-02-19T18:46:12Z,,0,0,09000064b91b93c0
FDA-2004-N-0451-0061,FDA,FDA-2004-N-0451,"Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 065",Notice,Announcement,2026-02-19T05:00:00Z,2026,2,2026-02-19T05:00:00Z,,2026-02-21T03:50:57Z,2026-03310,1,0,09000064b91bd3d2
FDA-2025-N-0342-0002,FDA,FDA-2025-N-0342,Sherri Insprucker: Final Debarment Order,Notice,Statutory Debarment,2026-02-19T05:00:00Z,2026,2,2026-02-19T05:00:00Z,,2026-02-23T20:20:09Z,2026-03254,1,0,09000064b91bd40a
FDA-2025-N-1928-0050,FDA,FDA-2025-N-1928,GRAS Notice (GRN) 1269 - Modified-monellin preparation – amendments,Notice,General Notice,2026-02-19T05:00:00Z,2026,2,2026-02-19T05:00:00Z,,2026-02-19T18:45:53Z,,0,0,09000064b91b93bf
FDA-2025-N-1927-0101,FDA,FDA-2025-N-1927,"GRAS Notice (GRN) 1165 - (R)-1,3-Butanediol",Notice,General Notice,2026-02-19T05:00:00Z,2026,2,2026-02-19T05:00:00Z,,2026-02-19T18:40:51Z,,0,0,09000064b91b93b8
FDA-2026-N-0498-0001,FDA,FDA-2026-N-0498,Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe Processing and Importing of Fish and Fishery Products,Notice,60 Day Proposed Information Collection,2026-02-19T05:00:00Z,2026,2,2026-02-19T05:00:00Z,2026-04-21T03:59:59Z,2026-02-19T20:20:32Z,2026-03311,1,0,09000064b91bd409
FDA-2025-N-0309-0002,FDA,FDA-2025-N-0309,Sherrie R. McCain: Final Debarment Order,Notice,Statutory Debarment,2026-02-19T05:00:00Z,2026,2,2026-02-19T05:00:00Z,,2026-02-23T20:20:44Z,2026-03252,1,0,09000064b91bd493
FDA-2026-N-1309-0001,FDA,FDA-2026-N-1309,Revocation of Authorization of Emergency Use of ExThera Medical Corporation Seraph 100 Microbind Affinity Blood Filter (Seraph 100); Availability,Notice,Announcement,2026-02-19T05:00:00Z,2026,2,2026-02-19T05:00:00Z,,2026-02-19T20:52:19Z,2026-03250,0,0,09000064b91bd344
FDA-2025-N-0345-0002,FDA,FDA-2025-N-0345,Justin Insprucker: Final Debarment Order,Notice,Statutory Debarment,2026-02-19T05:00:00Z,2026,2,2026-02-19T05:00:00Z,,2026-02-21T03:49:27Z,2026-03253,1,0,09000064b91bd4c5
FDA-2025-N-1928-0049,FDA,FDA-2025-N-1928,GRAS Notice (GRN) 1261 - 2'-Fucosyllactose - amendment,Notice,General Notice,2026-02-19T05:00:00Z,2026,2,2026-02-19T05:00:00Z,,2026-02-19T18:45:13Z,,0,0,09000064b91b93be
FDA-2025-E-0862-0006,FDA,FDA-2025-E-0862,Determination of Regulatory Review Period for Purposes of Patent Extension; SYMVESS,Notice,Determinations,2026-02-19T05:00:00Z,2026,2,2026-02-19T05:00:00Z,2026-04-21T03:59:59Z,2026-02-19T20:54:45Z,2026-03312,1,0,09000064b91bd33f
FDA-2025-N-1812-0002,FDA,FDA-2025-N-1812,Agency Information Collection Activities; Proposed Collection; Comment Request; Q-Submission and Early Payor Feedback Request Programs and Medical Device Development Tools,Notice,30 Day Proposed Information Collection,2026-02-18T05:00:00Z,2026,2,2026-02-18T05:00:00Z,2026-03-21T03:59:59Z,2026-02-18T18:59:05Z,2026-03096,1,0,09000064b91b9022
FDA-2024-N-1055-0004,FDA,FDA-2024-N-1055,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request Data To Support Social and Behavioral Research as Used by the Food and Drug Administration,Notice,30 Day Proposed Information Collection,2026-02-18T05:00:00Z,2026,2,2026-02-18T05:00:00Z,2026-03-21T03:59:59Z,2026-02-18T19:28:44Z,2026-03099,1,0,09000064b91b8e75
FDA-2025-N-0615-0002,FDA,FDA-2025-N-0615,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Quick Turnaround Testing of Communication Effectiveness,Notice,30 Day Proposed Information Collection,2026-02-18T05:00:00Z,2026,2,2026-02-18T05:00:00Z,2026-03-21T03:59:59Z,2026-02-18T18:51:59Z,2026-03095,1,0,09000064b91b90b3
FDA-2026-N-0497-0001,FDA,FDA-2026-N-0497,"Agency Information Collection Activities; Proposed Collection; Comment Request; Patent Term Restoration; Due Diligence Petitions; Filing, Format, and Content of Petitions",Notice,60 Day Proposed Information Collection,2026-02-18T05:00:00Z,2026,2,2026-02-18T05:00:00Z,2026-04-21T03:59:59Z,2026-02-18T19:12:13Z,2026-03094,1,0,09000064b91b8f13
FDA-2026-N-0958-0001,FDA,FDA-2026-N-0958,Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ZEVASKYN (Prademagene Zamikeracel),Notice,Announcement,2026-02-18T05:00:00Z,2026,2,,,2026-02-18T19:14:39Z,2026-03211,0,0,09000064b91b8ec7
FDA-2025-N-2652-0006,FDA,FDA-2025-N-2652,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents,Notice,30 Day Proposed Information Collection,2026-02-18T05:00:00Z,2026,2,2026-02-18T05:00:00Z,2026-03-21T03:59:59Z,2026-02-18T19:08:22Z,2026-03098,1,0,09000064b91b8fa6
FDA-2025-N-1560-0002,FDA,FDA-2025-N-1560,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Products Requirements,Notice,30 Day Proposed Information Collection,2026-02-18T05:00:00Z,2026,2,2026-02-18T05:00:00Z,2026-03-21T03:59:59Z,2026-02-18T19:24:09Z,2026-03097,1,0,09000064b91b8ec4
FDA-2025-N-0308-0003,FDA,FDA-2025-N-0308,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emerging Drug Safety Technology Program,Notice,30 Day Proposed Information Collection,2026-02-18T05:00:00Z,2026,2,2026-02-18T05:00:00Z,2026-03-21T03:59:59Z,2026-02-18T18:55:14Z,2026-03093,1,0,09000064b91b9066
FDA-2025-P-3575-0003,FDA,FDA-2025-P-3575,"Determination That TOLECTIN DS (Tolmetin Sodium) Capsule, Equivalent to 400 Milligrams Base, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness",Notice,Determinations,2026-02-18T05:00:00Z,2026,2,,,2026-02-18T19:03:46Z,2026-03213,0,0,09000064b91b901e
FDA-2025-E-0357-0006,FDA,FDA-2025-E-0357,Determination of Regulatory Review Period for Purposes of Patent Extension; ATTRUBY,Notice,Determinations,2026-02-13T05:00:00Z,2026,2,2026-02-13T05:00:00Z,2026-04-15T03:59:59Z,2026-02-13T19:41:11Z,2026-02971,1,0,09000064b91a9f20
FDA-2025-E-0359-0006,FDA,FDA-2025-E-0359,Determination of Regulatory Review Period for Purposes of Patent Extension; ATTRUBY,Notice,Determinations,2026-02-13T05:00:00Z,2026,2,2026-02-13T05:00:00Z,2026-04-15T03:59:59Z,2026-02-13T19:43:37Z,2026-02971,1,0,09000064b91a9ff7
FDA-2024-E-3532-0006,FDA,FDA-2024-E-3532,Determination of Regulatory Review Period for Purposes of Patent Extension; AMTAGVI,Notice,Determinations,2026-02-13T05:00:00Z,2026,2,2026-02-13T05:00:00Z,2026-04-15T03:59:59Z,2026-02-13T19:54:42Z,2026-02974,1,0,09000064b91aa73f
FDA-2025-E-2426-0006,FDA,FDA-2025-E-2426,Determination of Regulatory Review Period for Purposes of Patent Extension; BLUJEPA,Notice,Determinations,2026-02-13T05:00:00Z,2026,2,2026-02-13T05:00:00Z,2026-08-13T03:59:59Z,2026-02-13T20:03:13Z,2026-02901,1,0,09000064b91aa6fb
FDA-2024-E-3876-0006,FDA,FDA-2024-E-3876,Determination of Regulatory Review Period for Purposes of Patent Extension; RYTELO,Notice,Determinations,2026-02-13T05:00:00Z,2026,2,2026-02-13T05:00:00Z,2026-04-15T03:59:59Z,2026-02-20T20:30:13Z,2026-02903,1,0,09000064b91a8f34
FDA-2025-E-0483-0006,FDA,FDA-2025-E-0483,Determination of Regulatory Review Period for Purposes of Patent Extension; ALYFTREK,Notice,Determinations,2026-02-13T05:00:00Z,2026,2,2026-02-13T05:00:00Z,2026-04-15T03:59:59Z,2026-02-13T19:46:46Z,2026-02968,1,0,09000064b91aa742
FDA-2025-E-0362-0006,FDA,FDA-2025-E-0362,Determination of Regulatory Review Period for Purposes of Patent Extension; AUCATZYL,Notice,Determinations,2026-02-13T05:00:00Z,2026,2,2026-02-13T05:00:00Z,2026-04-15T03:59:59Z,2026-02-13T20:01:58Z,2026-02972,1,0,09000064b91a9ffe
FDA-2025-E-0370-0006,FDA,FDA-2025-E-0370,Determination of Regulatory Review Period for Purposes of Patent Extension; KEBILIDI,Notice,Determinations,2026-02-13T05:00:00Z,2026,2,2026-02-13T05:00:00Z,2026-04-15T03:59:59Z,2026-02-13T20:10:45Z,2026-02976,1,0,09000064b91a8f35
FDA-2025-E-0361-0006,FDA,FDA-2025-E-0361,Determination of Regulatory Review Period for Purposes of Patent Extension; AUCATZYL,Notice,Determinations,2026-02-13T05:00:00Z,2026,2,2026-02-13T05:00:00Z,2026-04-15T03:59:59Z,2026-02-13T20:00:39Z,2026-02972,1,0,09000064b91aa73c
FDA-2025-E-0360-0006,FDA,FDA-2025-E-0360,Determination of Regulatory Review Period for Purposes of Patent Extension; ATTRUBY,Notice,Determinations,2026-02-13T05:00:00Z,2026,2,2026-02-13T05:00:00Z,2026-04-15T03:59:59Z,2026-02-13T19:44:45Z,2026-02971,1,0,09000064b91a9ff8
FDA-2024-E-3872-0006,FDA,FDA-2024-E-3872,Determination of Regulatory Review Period for Purposes of Patent Extension; RYTELO,Notice,Determinations,2026-02-13T05:00:00Z,2026,2,2026-02-13T05:00:00Z,2026-04-15T03:59:59Z,2026-02-20T20:30:14Z,2026-02903,1,0,09000064b91aa6a8
FDA-2024-E-3873-0006,FDA,FDA-2024-E-3873,Determination of Regulatory Review Period for Purposes of Patent Extension; RYTELO,Notice,Determinations,2026-02-13T05:00:00Z,2026,2,2026-02-13T05:00:00Z,2026-04-15T03:59:59Z,2026-02-20T20:30:13Z,2026-02903,1,0,09000064b91a6c3d
FDA-2025-E-0492-0006,FDA,FDA-2025-E-0492,Determination of Regulatory Review Period for Purposes of Patent Extension; CRENESSITY,Notice,Determinations,2026-02-13T05:00:00Z,2026,2,2026-02-13T05:00:00Z,2026-04-15T03:59:59Z,2026-02-13T19:36:15Z,2026-02973,1,0,09000064b91a9f1c
FDA-2025-E-0491-0006,FDA,FDA-2025-E-0491,Determination of Regulatory Review Period for Purposes of Patent Extension; CRENESSITY,Notice,Determinations,2026-02-13T05:00:00Z,2026,2,2026-02-13T05:00:00Z,2026-04-15T03:59:59Z,2026-02-13T19:34:31Z,2026-02973,1,0,09000064b91aa8fb
FDA-2025-E-0508-0006,FDA,FDA-2025-E-0508,Determination of Regulatory Review Period for Purposes of Patent Extension; CRENESSITY,Notice,Determinations,2026-02-13T05:00:00Z,2026,2,2026-02-13T05:00:00Z,2026-04-15T03:59:59Z,2026-02-13T19:37:35Z,2026-02973,1,0,09000064b91a9f1e
FDA-2025-E-0358-0006,FDA,FDA-2025-E-0358,Determination of Regulatory Review Period for Purposes of Patent Extension; ATTRUBY,Notice,Determinations,2026-02-13T05:00:00Z,2026,2,2026-02-13T05:00:00Z,2026-04-15T03:59:59Z,2026-02-13T19:42:24Z,2026-02971,1,0,09000064b91a9ff6
FDA-2025-E-0369-0006,FDA,FDA-2025-E-0369,Determination of Regulatory Review Period for Purposes of Patent Extension; KEBILIDI,Notice,Determinations,2026-02-13T05:00:00Z,2026,2,2026-02-13T05:00:00Z,2026-04-15T03:59:59Z,2026-02-13T20:09:40Z,2026-02976,1,0,09000064b91a72ba
FDA-2023-D-2925-4518,FDA,FDA-2023-D-2925,Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals; Guidance for Industry; Availability,Notice,Notice of Availability,2026-02-13T05:00:00Z,2026,2,,,2026-02-13T20:12:58Z,2026-02934,0,0,09000064b91aa7ca
FDA-2024-E-3534-0006,FDA,FDA-2024-E-3534,Determination of Regulatory Review Period for Purposes of Patent Extension; AMTAGVI,Notice,Determinations,2026-02-13T05:00:00Z,2026,2,2026-02-13T05:00:00Z,2026-04-15T03:59:59Z,2026-02-13T19:56:16Z,2026-02974,1,0,09000064b91a9ffc
FDA-2025-E-0355-0006,FDA,FDA-2025-E-0355,Determination of Regulatory Review Period for Purposes of Patent Extension; ATTRUBY,Notice,Determinations,2026-02-13T05:00:00Z,2026,2,2026-02-13T05:00:00Z,2026-04-15T03:59:59Z,2026-02-13T19:39:29Z,2026-02971,1,0,09000064b91aa814
FDA-2024-E-3875-0006,FDA,FDA-2024-E-3875,Determination of Regulatory Review Period for Purposes of Patent Extension; RYTELO,Notice,Determinations,2026-02-13T05:00:00Z,2026,2,2026-02-13T05:00:00Z,2026-04-15T03:59:59Z,2026-02-20T20:30:13Z,2026-02903,1,0,09000064b91a8f33
FDA-2024-E-3874-0006,FDA,FDA-2024-E-3874,Determination of Regulatory Review Period for Purposes of Patent Extension; RYTELO,Notice,Determinations,2026-02-13T05:00:00Z,2026,2,2026-02-13T05:00:00Z,2026-04-15T03:59:59Z,2026-02-20T20:30:13Z,2026-02903,1,0,09000064b91a8f32
FDA-2025-N-0435-0002,FDA,FDA-2025-N-0435,Jeremy Spencer Brown: Final Debarment Order,Notice,Statutory Debarment,2026-02-12T05:00:00Z,2026,2,2026-02-12T05:00:00Z,,2026-02-12T18:22:54Z,2026-02786,1,0,09000064b91a64fb
FDA-2012-D-1197-0013,FDA,FDA-2012-D-1197,"Certification Process for Designated Medical Gases; Draft Guidance for Industry; Availability; Agency
Information Collection Activities; Proposed Collection; Comment Request",Notice,Notice of Availability,2026-02-12T05:00:00Z,2026,2,2026-02-12T05:00:00Z,,2026-02-12T18:33:11Z,2026-02789,0,0,09000064b91a649e
FDA-2026-N-0826-0001,FDA,FDA-2026-N-0826,"Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public
Docket; Request for Comments— United States (U.S.) 2026–2027 Influenza Vaccine Strain Composition",Notice,Request for Comments,2026-02-12T05:00:00Z,2026,2,2026-02-12T05:00:00Z,2026-03-12T03:59:59Z,2026-02-28T10:00:15Z,2026-02787,1,0,09000064b91a649f
FDA-2026-N-0302-0001,FDA,FDA-2026-N-0302,Butylated Hydroxyanisole (BHA); Request for Information,Notice,Requests for Information (RFI),2026-02-11T05:00:00Z,2026,2,2026-02-11T05:00:00Z,2026-04-14T03:59:59Z,2026-02-27T10:00:23Z,2026-02761,1,0,09000064b91a25bf
FDA-2023-N-5706-0003,FDA,FDA-2023-N-5706,Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program,Notice,Announcement,2026-02-11T05:00:00Z,2026,2,2026-02-11T05:00:00Z,,2026-02-11T19:17:34Z,2026-02768,0,0,09000064b91a26d1
FDA-2025-E-0152-0006,FDA,FDA-2025-E-0152,Determination of Regulatory Review Period for Purposes of Patent Extension; COBENFY,Notice,Determinations,2026-02-06T05:00:00Z,2026,2,2026-02-06T05:00:00Z,2026-08-06T03:59:59Z,2026-02-06T20:05:43Z,2026-02388,1,0,09000064b919467e
FDA-2026-D-0207-0001,FDA,FDA-2026-D-0207,"E22 General Considerations for Patient Preference Studies; International Council for Harmonisation; Draft
Guidance for Industry; Availability",Notice,Notice of Availability,2026-02-06T05:00:00Z,2026,2,2026-02-06T05:00:00Z,,2026-02-06T19:33:49Z,2026-02324,0,0,09000064b9195d41
FDA-2024-D-2033-0054,FDA,FDA-2024-D-2033,Agency Information Collection Activities; Proposed Collection; Comment Request; Expedited Programs for Serious Conditions—Accelerated Approval of Drugs and Biologics,Notice,60 Day Proposed Information Collection,2026-02-06T05:00:00Z,2026,2,2026-02-06T05:00:00Z,2026-04-08T03:59:59Z,2026-02-06T19:55:42Z,2026-02386,1,0,09000064b9195c65
FDA-2024-E-3536-0006,FDA,FDA-2024-E-3536,Determination of Regulatory Review Period for Purposes of Patent Extension; AURORA EV–ICD,Notice,Determinations,2026-02-06T05:00:00Z,2026,2,2026-02-06T05:00:00Z,,2026-02-06T20:29:55Z,2026-02383,0,0,09000064b9195b55
FDA-2025-E-0153-0006,FDA,FDA-2025-E-0153,Determination of Regulatory Review Period for Purposes of Patent Extension; COBENFY,Notice,Determinations,2026-02-06T05:00:00Z,2026,2,2026-02-06T05:00:00Z,2026-08-06T03:59:59Z,2026-02-06T20:06:34Z,2026-02388,1,0,09000064b919467f
FDA-2024-E-3539-0006,FDA,FDA-2024-E-3539,Determination of Regulatory Review Period for Purposes of Patent Extension; BEQVEZ,Notice,Determinations,2026-02-06T05:00:00Z,2026,2,2026-02-06T05:00:00Z,2026-08-06T03:59:59Z,2026-02-14T13:19:52Z,2026-02387,1,0,09000064b9195b4d
FDA-2024-E-3535-0006,FDA,FDA-2024-E-3535,Determination of Regulatory Review Period for Purposes of Patent Extension; AURORA EV–ICD,Notice,Determinations,2026-02-06T05:00:00Z,2026,2,2026-02-06T05:00:00Z,,2026-02-06T20:29:21Z,2026-02383,0,0,09000064b9196229
FDA-2026-N-0232-0001,FDA,FDA-2026-N-0232,Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments,Notice,Request for Comments,2026-02-06T05:00:00Z,2026,2,2026-02-06T05:00:00Z,2026-04-08T03:59:59Z,2026-02-26T10:00:18Z,2026-02377,1,0,09000064b9195af7
FDA-2025-E-1227-0006,FDA,FDA-2025-E-1227,Determination of Regulatory Review Period for Purposes of Patent Extension; ALFAPUMP,Notice,Determinations,2026-02-06T05:00:00Z,2026,2,2026-02-06T05:00:00Z,2026-04-08T03:59:59Z,2026-02-11T02:11:43Z,2026-02384,1,0,09000064b9195d0d
FDA-2025-N-1956-0002,FDA,FDA-2025-N-1956,Matthew Teltser: Final Debarment Order,Notice,General Notice,2026-02-06T05:00:00Z,2026,2,2026-02-06T05:00:00Z,,2026-02-06T20:25:04Z,2026-02349,0,0,09000064b9195b88