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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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19,583 rows where agency_id = "FDA" and document_type = "Notice" sorted by posted_date descending

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agency_id 1

  • FDA · 19,583 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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 Civil money penalties:biologics, drugs and medical devices 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 Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards 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

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
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