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

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

751 rows where agency_id = "FDA", document_type = "Notice" and posted_year = 2025 sorted by posted_date descending

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  • 2025 · 751 ✖

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  • Notice · 751 ✖

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  • FDA · 751 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2025-N-1928-0026 FDA FDA-2025-N-1928 GRAS Notice (GRN) 1250 - Alternansucrase enzyme preparation produced by Escherichia coli Notice General Notice 2025-12-30T05:00:00Z 2025 12 2025-12-30T05:00:00Z   2025-12-30T23:09:02Z   0 0 09000064b910d339
FDA-2025-N-1928-0033 FDA FDA-2025-N-1928 GRAS Notice (GRN) 1278 - Lactiplantibacillus plantarum CGMCC 6312 Notice General Notice 2025-12-30T05:00:00Z 2025 12 2025-12-30T05:00:00Z   2025-12-30T23:17:03Z   0 0 09000064b910d360
FDA-2025-N-1928-0031 FDA FDA-2025-N-1928 GRAS Notice (GRN) 1273 - Lacto-N-tetraose Notice General Notice 2025-12-30T05:00:00Z 2025 12 2025-12-30T05:00:00Z   2025-12-30T23:15:50Z   0 0 09000064b910d33f
FDA-2025-N-1928-0032 FDA FDA-2025-N-1928 GRAS Notice (GRN) 1276 - Cellulase enzyme preparation produced by Trichoderma reesei Notice General Notice 2025-12-30T05:00:00Z 2025 12 2025-12-30T05:00:00Z   2025-12-30T23:16:15Z   0 0 09000064b910d340
FDA-2025-N-1928-0029 FDA FDA-2025-N-1928 GRAS Notice GRN 1269 - Modified monellin preparation produced by Komagataella phaffii CBS 150005 - Part 1 of 2 Notice General Notice 2025-12-30T05:00:00Z 2025 12 2025-12-30T05:00:00Z   2025-12-30T23:12:21Z   0 0 09000064b910d33d
FDA-2025-N-1927-0099 FDA FDA-2025-N-1927 GRAS Notice (GRN) 1226 - Orange (Citrus sinensis) extract - amendments Notice General Notice 2025-12-30T05:00:00Z 2025 12 2025-12-30T05:00:00Z   2025-12-30T23:07:43Z   0 0 09000064b910d2f3
FDA-2025-N-1928-0027 FDA FDA-2025-N-1928 GRAS Notice (GRN) 1266 - Wheat fiber extract from wheat (Triticumaestivum) Notice General Notice 2025-12-30T05:00:00Z 2025 12 2025-12-30T05:00:00Z   2025-12-30T23:10:03Z   0 0 09000064b910d33a
FDA-2025-N-1928-0028 FDA FDA-2025-N-1928 GRAS Notice (GRN) 1267 - Sunflower lecithin Notice General Notice 2025-12-30T05:00:00Z 2025 12 2025-12-30T05:00:00Z   2025-12-30T23:10:59Z   0 0 09000064b910d33b
FDA-2025-N-1928-0030 FDA FDA-2025-N-1928 GRAS Notice GRN 1269 - Modified monellin preparation produced by Komagataella phaffii CBS 150005 - Part 2 of 2 Notice General Notice 2025-12-30T05:00:00Z 2025 12 2025-12-30T05:00:00Z   2025-12-30T23:15:10Z   0 0 09000064b910d33e
FDA-2025-N-7022-0001 FDA FDA-2025-N-7022 Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products; Notice of Meeting; Establishment of a Public Docket; Request for Comments Notice Request for Comments 2025-12-29T05:00:00Z 2025 12 2025-12-29T05:00:00Z 2026-03-13T03:59:59Z 2026-02-14T13:17:33Z 2025-23851 1 0 09000064b910a287
FDA-2024-E-1284-0008 FDA FDA-2024-E-1284 Determination of Regulatory Review Period for Purposes of Patent Extension; ADZYNMA Notice Determinations 2025-12-29T05:00:00Z 2025 12 2025-12-29T05:00:00Z 2026-02-28T04:59:59Z 2025-12-29T19:32:46Z 2025-23864 0 0 09000064b910a420
FDA-2024-E-1293-0006 FDA FDA-2024-E-1293 Determination of Regulatory Review Period for Purposes of Patent Extension; ZELSUVMI Notice Determinations 2025-12-29T05:00:00Z 2025 12 2025-12-29T05:00:00Z 2026-02-28T04:59:59Z 2026-02-28T10:00:12Z 2025-23868 0 0 09000064b910a4a8
FDA-2024-E-1287-0007 FDA FDA-2024-E-1287 Determination of Regulatory Review Period for Purposes of Patent Extension; ADZYNMA Notice Determinations 2025-12-29T05:00:00Z 2025 12 2025-12-29T05:00:00Z 2026-02-28T04:59:59Z 2025-12-29T19:37:21Z 2025-23864 0 0 09000064b910aaad
FDA-2024-E-1286-0006 FDA FDA-2024-E-1286 Determination of Regulatory Review Period for Purposes of Patent Extension; ADZYNMA Notice Determinations 2025-12-29T05:00:00Z 2025 12 2025-12-29T05:00:00Z 2026-02-28T04:59:59Z 2025-12-29T19:35:54Z 2025-23864 0 0 09000064b910aaac
FDA-2025-N-6971-0001 FDA FDA-2025-N-6971 Authorization of Emergency Use for Two Animal Drugs for the Treatment of New World Screwworm; Availability Notice Announcement 2025-12-29T05:00:00Z 2025 12 2025-12-29T05:00:00Z   2025-12-29T20:06:23Z 2025-23914 0 0 09000064b910a2c5
FDA-2024-E-3865-0007 FDA FDA-2024-E-3865 Determination of Regulatory Review Period for Purposes of Patent Extension; OJEMDA Notice Determinations 2025-12-29T05:00:00Z 2025 12 2025-12-29T05:00:00Z 2026-02-28T04:59:59Z 2025-12-29T19:57:00Z 2025-23867 0 0 09000064b910a301
FDA-2025-N-4684-0001 FDA FDA-2025-N-4684 Egis Pharmaceuticals Limited, et.al.; Proposal To Withdraw Approval of Three Abbreviated New Drug Applications; Opportunity for a Hearing Notice Withdrawal 2025-12-29T05:00:00Z 2025 12 2025-12-29T05:00:00Z 2026-02-28T04:59:59Z 2025-12-29T19:49:40Z 2025-23870 0 0 09000064b910a3d3
FDA-2025-N-3656-0002 FDA FDA-2025-N-3656 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practices for Positron Emission Tomography Drugs Notice 30 Day Proposed Information Collection 2025-12-29T05:00:00Z 2025 12 2025-12-29T05:00:00Z 2026-01-29T04:59:59Z 2026-01-31T13:12:34Z 2025-23859 0 0 09000064b910a46c
FDA-2025-P-5560-0023 FDA FDA-2025-P-5560 Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices Notice Announcement 2025-12-29T05:00:00Z 2025 12 2025-12-29T05:00:00Z 2026-02-28T04:59:59Z 2026-02-28T10:00:12Z 2025-23901 0 0 09000064b910a2ff
FDA-2024-E-1285-0007 FDA FDA-2024-E-1285 Determination of Regulatory Review Period for Purposes of Patent Extension; ADZYNMA Notice Determinations 2025-12-29T05:00:00Z 2025 12 2025-12-29T05:00:00Z 2026-02-28T04:59:59Z 2025-12-29T19:34:39Z 2025-23864 0 0 09000064b91077dc
FDA-2024-E-1288-0007 FDA FDA-2024-E-1288 Determination of Regulatory Review Period for Purposes of Patent Extension; ADZYNMA Notice Determinations 2025-12-29T05:00:00Z 2025 12 2025-12-29T05:00:00Z 2026-02-28T04:59:59Z 2025-12-29T19:39:03Z 2025-23864 0 0 09000064b910acd7
FDA-2025-E-0917-0006 FDA FDA-2025-E-0917 Determination of Regulatory Review Period for Purposes of Patent Extension; ALHEMO Notice Determinations 2025-12-29T05:00:00Z 2025 12 2025-12-29T05:00:00Z 2026-02-28T04:59:59Z 2025-12-29T20:38:53Z 2025-23863 0 0 09000064b9106d07
FDA-2025-N-6896-0001 FDA FDA-2025-N-6896 Over-the-Counter Monograph Drug User Fee Amendments—OTC Monograph Order Request Fee Rates for Fiscal Year 2026 Notice Announcement 2025-12-29T05:00:00Z 2025 12 2025-12-29T05:00:00Z   2025-12-29T19:44:43Z 2025-23852 0 0 09000064b910a41f
FDA-2023-E-3236-0006 FDA FDA-2023-E-3236 Determination of Regulatory Review Period for Purposes of Patent Extension; LEQEMBI Notice Determinations 2025-12-29T05:00:00Z 2025 12 2025-12-29T05:00:00Z 2026-02-28T04:59:59Z 2025-12-29T20:09:09Z 2025-23865 0 0 09000064b910a288
FDA-2025-E-0923-0006 FDA FDA-2025-E-0923 Determination of Regulatory Review Period for Purposes of Patent Extension; ROMVIMZA Notice Determinations 2025-12-29T05:00:00Z 2025 12 2025-12-29T05:00:00Z 2026-02-28T04:59:59Z 2025-12-29T19:54:00Z 2025-23862 0 0 09000064b910a397
FDA-2025-N-1210-0002 FDA FDA-2025-N-1210 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance of Medical Devices Notice 30 Day Proposed Information Collection 2025-12-23T05:00:00Z 2025 12 2025-12-23T05:00:00Z 2026-01-22T04:59:59Z 2026-01-24T13:18:31Z 2025-23630 0 0 09000064b91065e6
FDA-2023-D-2204-0005 FDA FDA-2023-D-2204 Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability Notice Notice of Availability 2025-12-23T05:00:00Z 2025 12 2025-12-23T05:00:00Z   2025-12-23T18:49:14Z 2025-23707 0 0 09000064b91065e7
FDA-2024-N-4731-0003 FDA FDA-2024-N-4731 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2025-12-19T05:00:00Z 2025 12 2025-12-19T05:00:00Z   2025-12-19T20:08:09Z 2025-23483 0 0 09000064b90f0496
FDA-2025-N-0383-0006 FDA FDA-2025-N-0383 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2025-12-19T05:00:00Z 2025 12 2025-12-19T05:00:00Z   2025-12-19T20:14:36Z 2025-23483 0 0 09000064b90f049b
FDA-2025-N-6076-0001 FDA FDA-2025-N-6076 Agency Information Collection Activities; Proposed Collection; Comment Request; Required Warnings for Cigarette Packages and Advertisements Notice 60 Day Proposed Information Collection 2025-12-19T05:00:00Z 2025 12 2025-12-19T05:00:00Z 2026-02-18T04:59:59Z 2026-01-24T13:18:20Z 2025-23474 0 0 09000064b90f519a
FDA-2024-N-5468-0010 FDA FDA-2024-N-5468 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2025-12-19T05:00:00Z 2025 12 2025-12-19T05:00:00Z   2025-12-19T20:09:54Z 2025-23483 0 0 09000064b90f0498
FDA-2025-P-1562-0004 FDA FDA-2025-P-1562 Determination That DEXCHLORPHENIRAMINE MALEATE (Dexchlorpheniramine Maleate, Oral Syrup, 2 Milligrams/5 Milliliters) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2025-12-19T05:00:00Z 2025 12 2025-12-19T05:00:00Z   2025-12-19T19:43:25Z 2025-23419 0 0 09000064b90f5231
FDA-2025-N-0338-0004 FDA FDA-2025-N-0338 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2025-12-19T05:00:00Z 2025 12 2025-12-19T05:00:00Z   2025-12-19T20:45:55Z 2025-23483 0 0 09000064b90f5736
FDA-2025-N-0082-0009 FDA FDA-2025-N-0082 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2025-12-19T05:00:00Z 2025 12 2025-12-19T05:00:00Z   2025-12-19T20:50:27Z 2025-23483 0 0 09000064b90f573c
FDA-2025-P-1304-0004 FDA FDA-2025-P-1304 Determination That EFFEXOR XR (Venlafaxine Hydrochloride) Extended- Release Capsule, 100 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2025-12-19T05:00:00Z 2025 12 2025-12-19T05:00:00Z   2025-12-19T21:21:26Z 2025-23408 0 0 09000064b90f5195
FDA-2024-N-5603-0004 FDA FDA-2024-N-5603 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2025-12-19T05:00:00Z 2025 12 2025-12-19T05:00:00Z   2025-12-19T20:06:25Z 2025-23483 0 0 09000064b90f51e3
FDA-2024-N-5234-0003 FDA FDA-2024-N-5234 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2025-12-19T05:00:00Z 2025 12 2025-12-19T05:00:00Z   2025-12-19T20:11:44Z 2025-23483 0 0 09000064b90f0499
FDA-2025-N-0123-0006 FDA FDA-2025-N-0123 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2025-12-19T05:00:00Z 2025 12 2025-12-19T05:00:00Z   2025-12-19T20:13:18Z 2025-23483 0 0 09000064b90f049a
FDA-2025-N-4683-0001 FDA FDA-2025-N-4683 Issuance of Priority Review Voucher; Rare Pediatric Disease Product; FORZINITY (Elamipretide) Notice Announcement 2025-12-19T05:00:00Z 2025 12 2025-12-19T05:00:00Z   2025-12-19T19:35:42Z 2025-23409 0 0 09000064b90f5277
FDA-2023-D-5021-0018 FDA FDA-2023-D-5021 Processes and Practices Applicable to Bioresearch Monitoring Inspections; Guidance for Industry; Availability Notice Notice of Availability 2025-12-19T05:00:00Z 2025 12 2025-12-19T05:00:00Z   2025-12-19T20:54:43Z 2025-23404 0 0 09000064b90f519d
FDA-2025-N-0183-0005 FDA FDA-2025-N-0183 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2025-12-19T05:00:00Z 2025 12 2025-12-19T05:00:00Z   2025-12-19T20:48:14Z 2025-23483 0 0 09000064b90f573a
FDA-2025-N-0349-0006 FDA FDA-2025-N-0349 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2025-12-19T05:00:00Z 2025 12 2025-12-19T05:00:00Z   2025-12-19T20:49:25Z 2025-23483 0 0 09000064b90f573b
FDA-2025-N-4682-0001 FDA FDA-2025-N-4682 Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) Notice Notice of Approval 2025-12-19T05:00:00Z 2025 12 2025-12-19T05:00:00Z   2025-12-19T20:02:51Z 2025-23410 0 0 09000064b90f51e4
FDA-2023-D-4395-0033 FDA FDA-2023-D-4395 Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2025-12-18T05:00:00Z 2025 12     2025-12-18T18:40:06Z 2025-23252 0 0 09000064b90ee7f9
FDA-2025-D-2246-0001 FDA FDA-2025-D-2246 Questions and Answers Regarding Mandatory Cosmetics Recalls: Draft Guidance for Industry; Availability Notice Notice of Availability 2025-12-18T05:00:00Z 2025 12     2025-12-18T18:30:54Z 2025-23249 0 0 09000064b90eed0c
FDA-2021-D-0368-0012 FDA FDA-2021-D-0368 Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices; Guidance for Investigators, Industry, and Institutional Review Boards; Availability Notice Notice of Availability 2025-12-16T05:00:00Z 2025 12 2025-12-16T05:00:00Z   2025-12-16T18:17:17Z 2025-22869 0 0 09000064b90da8c2
FDA-2020-D-2099-0012 FDA FDA-2020-D-2099 Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/ Bioequivalence Studies; Guidance for Industry; Availability Notice Notice of Availability 2025-12-16T05:00:00Z 2025 12 2025-12-16T05:00:00Z   2025-12-16T18:44:45Z 2025-22870 0 0 09000064b90da7e0
FDA-2024-P-2952-0006 FDA FDA-2024-P-2952 Determination That LUNELLE (Estradiol Cypionate and Medroxyprogesterone Acetate) Injectable, 5 Milligrams/0.5 Milliliter and 25 Milligrams/0.5 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2025-12-12T05:00:00Z 2025 12 2025-12-12T05:00:00Z   2025-12-12T22:12:49Z 2025-22680 0 0 09000064b90cb51b
FDA-2025-N-6494-0001 FDA FDA-2025-N-6494 Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use Notice Notice of Availability 2025-12-12T05:00:00Z 2025 12 2025-12-12T05:00:00Z 2026-01-27T04:59:59Z 2026-01-31T13:11:51Z 2025-22649 0 0 09000064b90c85ec
FDA-2025-N-6077-0001 FDA FDA-2025-N-6077 Pfizer Inc., U.S. Agent for King Pharmaceuticals LLC, et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications Notice Withdrawal 2025-12-12T05:00:00Z 2025 12 2025-12-12T05:00:00Z   2025-12-12T19:37:48Z 2025-22683 0 0 09000064b90c8624
FDA-2020-P-1617-0005 FDA FDA-2020-P-1617 Determination That BACTROBAN (Mupirocin) Nasal Ointment, 2%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2025-12-12T05:00:00Z 2025 12 2025-12-12T05:00:00Z   2025-12-12T19:43:45Z 2025-22682 0 0 09000064b90c85b0
FDA-2025-N-4732-0001 FDA FDA-2025-N-4732 Determination That ZANTAC (Ranitidine Hydrochloride) Injection, Equivalent to 25 Milligrams Base/ Milliliter, Has Not Been Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2025-12-12T05:00:00Z 2025 12 2025-12-12T05:00:00Z   2025-12-12T19:55:43Z 2025-22676 0 0 09000064b90c85aa
FDA-2025-N-4734-0001 FDA FDA-2025-N-4734 Determination That DEMEROL (Meperidine Hydrochloride) Tablet, 100 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2025-12-12T05:00:00Z 2025 12 2025-12-12T05:00:00Z   2025-12-12T19:21:36Z 2025-22681 0 0 09000064b90c8657
FDA-2025-N-5997-0001 FDA FDA-2025-N-5997 Biosimilar User Fee Act; Stakeholder Consultation Meetings on Biosimilar User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate Notice General Notice 2025-12-12T05:00:00Z 2025 12 2025-12-12T05:00:00Z   2025-12-13T00:47:14Z 2025-22619 0 0 09000064b90c85ad
FDA-2025-N-6743-0001 FDA FDA-2025-N-6743 Food and Drug Administration Expert Panel on Testosterone Replacement Therapy for Men; Request for Information Notice Requests for Information (RFI) 2025-12-11T05:00:00Z 2025 12 2025-12-11T05:00:00Z 2026-02-10T04:59:59Z 2026-02-20T20:29:54Z 2025-22466 0 0 09000064b90c309f
FDA-2024-E-1291-0006 FDA FDA-2024-E-1291 Determination of Regulatory Review Period for Purposes of Patent Extension; FILSUVEZ Notice Determinations 2025-12-10T05:00:00Z 2025 12 2025-12-10T05:00:00Z 2026-02-10T04:59:59Z 2026-02-07T13:13:03Z 2025-22380 0 0 09000064b90c192e
FDA-2024-E-1292-0006 FDA FDA-2024-E-1292 Determination of Regulatory Review Period for Purposes of Patent Extension; FILSUVEZ Notice Determinations 2025-12-10T05:00:00Z 2025 12 2025-12-10T05:00:00Z 2026-02-10T04:59:59Z 2026-02-07T13:13:03Z 2025-22380 0 0 09000064b90c192f
FDA-2024-E-1290-0006 FDA FDA-2024-E-1290 Determination of Regulatory Review Period for Purposes of Patent Extension; FILSUVEZ Notice Determinations 2025-12-10T05:00:00Z 2025 12 2025-12-10T05:00:00Z 2026-02-10T04:59:59Z 2026-02-07T13:13:03Z 2025-22380 0 0 09000064b90c167a
FDA-2019-D-5473-0028 FDA FDA-2019-D-5473 Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Availability Notice Notice of Availability 2025-12-10T05:00:00Z 2025 12     2025-12-10T20:21:09Z 2025-22427 0 0 09000064b90c159b
FDA-2025-E-0861-0006 FDA FDA-2025-E-0861 Determination of Regulatory Review Period for Purposes of Patent Extension; GRAFAPEX Notice Determinations 2025-12-10T05:00:00Z 2025 12 2025-12-10T05:00:00Z 2026-02-10T04:59:59Z 2025-12-10T20:10:46Z 2025-22382 0 0 09000064b90c15e6
FDA-2025-N-2195-0002 FDA FDA-2025-N-2195 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Humanitarian Use Devices Notice 30 Day Proposed Information Collection 2025-12-09T05:00:00Z 2025 12 2025-12-09T05:00:00Z 2026-01-09T04:59:59Z 2026-01-10T13:17:31Z 2025-22278 0 0 09000064b90b58f1
FDA-2025-N-4942-0001 FDA FDA-2025-N-4942 Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Standards Quality Act Requirements Notice 60 Day Proposed Information Collection 2025-12-09T05:00:00Z 2025 12 2025-12-09T05:00:00Z 2026-02-10T04:59:59Z 2025-12-09T19:22:07Z 2025-22276 0 0 09000064b90bbad6
FDA-2025-N-4250-0001 FDA FDA-2025-N-4250 Agency Information Collection Activities; Proposed Collection; Comment Request; Establishment, Maintenance, and Availability of Records; Additional Traceability Records for Certain Foods Notice 60 Day Proposed Information Collection 2025-12-09T05:00:00Z 2025 12 2025-12-09T05:00:00Z 2026-02-10T04:59:59Z 2026-02-14T13:16:37Z 2025-22277 0 0 09000064b90bbad9
FDA-2025-N-6461-0001 FDA FDA-2025-N-6461 Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot Notice Announcement 2025-12-08T05:00:00Z 2025 12 2025-12-08T05:00:00Z   2025-12-09T00:26:12Z 2025-22190 0 0 09000064b90b56a1
FDA-2007-D-0369-2419 FDA FDA-2007-D-0369 Product-Specific Guidance on Estradiol; Draft Guidance for Industry; Availability Notice Notice of Availability 2025-12-08T05:00:00Z 2025 12 2025-12-08T05:00:00Z   2025-12-09T00:20:26Z 2025-22249 0 0 09000064b90b585d
FDA-2025-N-5791-0001 FDA FDA-2025-N-5791 Revocation of Emergency Use of a Drug Product During the COVID–19 Pandemic; Availability Notice Announcement 2025-12-08T05:00:00Z 2025 12 2025-12-08T05:00:00Z   2025-12-09T00:58:57Z 2025-22211 0 0 09000064b90b5810
FDA-2007-D-0369-2337 FDA FDA-2007-D-0369 Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability Notice Notice of Availability 2025-12-05T05:00:00Z 2025 12     2025-12-05T19:22:56Z 2025-22131 0 0 09000064b90b00b7
FDA-2023-D-2439-0010 FDA FDA-2023-D-2439 QTc Information in Human Prescription Drug and Biological Product Labeling; Guidance for Industry; Availability Notice Notice of Availability 2025-12-03T05:00:00Z 2025 12 2025-12-03T05:00:00Z   2025-12-03T19:27:24Z 2025-21798 0 0 09000064b90abe6a
FDA-2025-D-4634-0001 FDA FDA-2025-D-4634 Monoclonal Antibodies: Streamlined Nonclinical Safety Studies; Draft Guidance for Industry; Availability Notice Notice of Availability 2025-12-03T05:00:00Z 2025 12 2025-12-03T05:00:00Z   2025-12-03T19:23:31Z 2025-21864 0 0 09000064b90abea8
FDA-2025-N-4731-0001 FDA FDA-2025-N-4731 Increasing Access to Nonprescription Drugs; Request for Information Notice Requests for Information (RFI) 2025-12-02T05:00:00Z 2025 12 2025-12-02T05:00:00Z 2026-02-03T04:59:59Z 2026-02-07T13:12:35Z 2025-21728 0 0 09000064b90a9a1a
FDA-2025-D-4678-0001 FDA FDA-2025-D-4678 Q3E Guideline for Extractables and Leachables; International Council for Harmonisation; Draft Guidance for Industry; Availability Notice Notice of Availability 2025-12-01T05:00:00Z 2025 12     2025-12-01T19:17:15Z 2025-21702 0 0 09000064b90a5cdd
FDA-2024-N-3945-0008 FDA FDA-2024-N-3945 FDA’s Strategy Document on Innovative Manufacturing Technologies Notice Notice of Availability 2025-12-01T05:00:00Z 2025 12 2025-12-01T05:00:00Z   2025-12-04T10:00:27Z 2025-21692 1 0 09000064b90a5c2f
FDA-2003-D-0431-0064 FDA Current Good Manufacturing Practices for Medical Gases FDA-2003-D-0431 Medical Gases—Current Good Manufacturing Practice; Draft Guidance for Industry; Availability Notice Notice of Availability 2025-12-01T05:00:00Z 2025 12 2025-12-01T05:00:00Z 2026-01-31T04:59:59Z 2026-01-31T13:11:09Z 2025-21689 0 0 09000064b90a5a7c
FDA-2025-N-0348-0002 FDA FDA-2025-N-0348 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Center for Devices and Radiological Health Appeals Processes Notice 30 Day Proposed Information Collection 2025-11-28T05:00:00Z 2025 11 2025-11-28T05:00:00Z 2025-12-30T04:59:59Z 2025-11-28T19:42:40Z 2025-21320 0 0 09000064b90a26e6
FDA-2025-D-5715-0001 FDA FDA-2025-D-5715 Cross-Center Master Files: Where To Submit; Draft Guidance for Industry; Availability Notice Notice of Availability 2025-11-26T05:00:00Z 2025 11     2025-11-26T19:08:51Z 2025-21224 0 0 09000064b909ec11
FDA-2025-N-1928-0025 FDA FDA-2025-N-1928 GRAS Notice (GRN) 1268 – Mycelial biomass Notice General Notice 2025-11-25T05:00:00Z 2025 11 2025-11-25T05:00:00Z   2025-11-25T20:38:16Z   0 0 09000064b909afac
FDA-2025-N-1137-0002 FDA FDA-2025-N-1137 Nicole Shelby Randall: Final Debarment Order Notice Statutory Debarment 2025-11-25T05:00:00Z 2025 11 2025-11-25T05:00:00Z   2025-11-26T10:00:08Z 2025-21075 1 0 09000064b90936f8
FDA-2025-N-1109-0003 FDA FDA-2025-N-1109 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization Notice 30 Day Proposed Information Collection 2025-11-24T05:00:00Z 2025 11 2025-11-24T05:00:00Z 2025-12-25T04:59:59Z 2025-12-25T10:00:09Z 2025-20774 0 0 09000064b9092f91
FDA-2015-N-3326-0045 FDA FDA-2015-N-3326 Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments Notice Request for Comments 2025-11-24T05:00:00Z 2025 11 2025-11-24T05:00:00Z 2026-01-03T04:59:59Z 2026-01-03T13:15:26Z 2025-20654 0 0 09000064b9093657
FDA-2024-E-5140-0006 FDA FDA-2024-E-5140 Determination of Regulatory Review Period for Purposes of Patent Extension; ENVISION MAMMOGRAPHY PLATFORM Notice Determinations 2025-11-24T05:00:00Z 2025 11 2025-11-24T05:00:00Z 2026-05-27T03:59:59Z 2026-01-24T13:16:48Z 2025-20667 1 0 09000064b908e3f0
FDA-2025-N-4348-0001 FDA FDA-2025-N-4348 Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act Notice 60 Day Proposed Information Collection 2025-11-24T05:00:00Z 2025 11 2025-11-24T05:00:00Z 2026-01-24T04:59:59Z 2026-01-24T13:16:51Z 2025-20773 0 0 09000064b909356a
FDA-2025-N-1115-0003 FDA FDA-2025-N-1115 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emergency Use Authorization of Medical Products Notice 30 Day Proposed Information Collection 2025-11-24T05:00:00Z 2025 11 2025-11-24T05:00:00Z 2025-12-25T04:59:59Z 2025-12-22T10:00:19Z 2025-20771 0 0 09000064b909365b
FDA-2025-N-2976-0003 FDA FDA-2025-N-2976 Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine; Public Workshop; Request for Comments Notice Request for Comments 2025-11-24T05:00:00Z 2025 11 2025-11-24T05:00:00Z 2026-01-17T04:59:59Z 2026-01-17T13:20:26Z 2025-20658 0 0 09000064b909369d
FDA-2024-E-5139-0006 FDA FDA-2024-E-5139 Determination of Regulatory Review Period for Purposes of Patent Extension; ENVISION MAMMOGRAPHY PLATFORM Notice Determinations 2025-11-24T05:00:00Z 2025 11 2025-11-24T05:00:00Z 2026-05-27T03:59:59Z 2026-01-24T13:16:48Z 2025-20667 1 0 09000064b908e3ef
FDA-2024-E-5141-0006 FDA FDA-2024-E-5141 Determination of Regulatory Review Period for Purposes of Patent Extension; ENVISION MAMMOGRAPHY PLATFORM Notice Determinations 2025-11-24T05:00:00Z 2025 11 2025-11-24T05:00:00Z 2026-05-27T03:59:59Z 2026-01-24T13:16:50Z 2025-20667 1 0 09000064b9092f99
FDA-2025-N-0835-0020 FDA FDA-2025-N-0835 Tobacco Products Scientific Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments Notice Request for Comments 2025-11-24T05:00:00Z 2025 11 2025-11-24T05:00:00Z 2026-01-22T04:59:59Z 2026-01-24T13:16:50Z 2025-20768 0 0 09000064b90930ce
FDA-2025-N-1108-0002 FDA FDA-2025-N-1108 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 510(k) Third-Party Review Program Notice 30 Day Proposed Information Collection 2025-11-24T05:00:00Z 2025 11 2025-11-24T05:00:00Z 2025-12-25T04:59:59Z 2025-11-24T21:26:58Z 2025-20772 0 0 09000064b90930d4
FDA-2025-N-5935-0001 FDA FDA-2025-N-5935 Intercept Pharmaceuticals, Inc., et al.; Withdrawal of Approval of New Drug Application for OCALIVA (Obeticholic Acid) Tablets, 5 Milligrams and 10 Milligrams, and Three Abbreviated New Drug Applications for Obeticholic Acid Tablets, 5 Milligrams and 10 Milligrams Notice Withdrawal 2025-11-24T05:00:00Z 2025 11 2025-11-24T05:00:00Z   2025-11-24T18:52:14Z 2025-20767 0 0 09000064b90936f4
FDA-2024-E-5681-0006 FDA FDA-2024-E-5681 Determination of Regulatory Review Period for Purposes of Patent Extension; ALTIUS DIRECT ELECTRICAL NERVE STIMULATION SYSTEM Notice Determinations 2025-11-24T05:00:00Z 2025 11 2025-11-24T05:00:00Z 2026-05-27T03:59:59Z 2025-11-24T19:32:14Z 2025-20668 1 0 09000064b9093521
FDA-2025-N-0008-0011 FDA FDA-2025-N-0008 General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice—Establishment of Public Docket; Request for Comments Notice General Notice 2025-11-21T05:00:00Z 2025 11 2025-11-21T05:00:00Z 2026-01-10T04:59:59Z 2026-01-10T13:16:41Z 2025-20608 0 0 09000064b908d631
FDA-2024-N-0668-0004 FDA FDA-2024-N-0668 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Small Dispensers Assessment Under the Drug Supply Chain Security Act Notice 30 Day Proposed Information Collection 2025-11-21T05:00:00Z 2025 11 2025-11-21T05:00:00Z 2025-12-23T04:59:59Z 2025-12-19T10:00:14Z 2025-20643 0 0 09000064b908d8c7
FDA-2007-D-0369-2254 FDA FDA-2007-D-0369 Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability Notice Notice of Availability 2025-11-21T05:00:00Z 2025 11     2025-11-21T19:13:10Z 2025-20548 0 0 09000064b908d6cf
FDA-2011-D-0605-0059 FDA FDA-2011-D-0605 Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies; Draft Guidance for Industry; Availability Notice Notice of Availability 2025-11-20T05:00:00Z 2025 11 2025-11-20T05:00:00Z   2025-11-20T19:15:15Z 2025-20380 0 0 09000064b908a856
FDA-2025-N-1928-0022 FDA FDA-2025-N-1928 GRAS Notice (GRN) 1275 – Sialyllactose sodium salt Notice General Notice 2025-11-19T05:00:00Z 2025 11 2025-11-19T05:00:00Z   2025-11-19T19:29:21Z   0 0 09000064b9088b1c
FDA-2025-N-1928-0023 FDA FDA-2025-N-1928 GRAS Notice (GRN) 1277 – Parabacteroides goldsteinii Notice General Notice 2025-11-19T05:00:00Z 2025 11 2025-11-19T05:00:00Z   2025-11-19T19:29:26Z   0 0 09000064b9088b1d
FDA-2025-N-1928-0024 FDA FDA-2025-N-1928 GRAS Notice (GRN) 1279 – Saccharomyces cerevisiae Notice General Notice 2025-11-19T05:00:00Z 2025 11 2025-11-19T05:00:00Z   2025-11-19T19:29:33Z   0 0 09000064b9088b28
FDA-2025-N-1928-0020 FDA FDA-2025-N-1928 GRAS Notice (GRN) 1272 – Lacto-N-neotetraose Notice General Notice 2025-11-19T05:00:00Z 2025 11 2025-11-19T05:00:00Z   2025-11-19T19:29:06Z   0 0 09000064b9088b1a
FDA-2025-N-1928-0021 FDA FDA-2025-N-1928 GRAS Notice (GRN) 1274 – 2’-Fucosyllactose Notice General Notice 2025-11-19T05:00:00Z 2025 11 2025-11-19T05:00:00Z   2025-11-19T19:29:14Z   0 0 09000064b9088b1b
FDA-2025-N-1928-0015 FDA FDA-2025-N-1928 GRAS Notice (GRN) 1264 – Lacticaseibacillus rhamnosus Notice General Notice 2025-11-19T05:00:00Z 2025 11 2025-11-19T05:00:00Z   2025-11-19T19:28:38Z   0 0 09000064b9088b14
FDA-2025-N-1927-0098 FDA FDA-2025-N-1927 GRAS Notice (GRN) 1232 – Lacticaseibacillus paracasei - Amendments Notice General Notice 2025-11-19T05:00:00Z 2025 11 2025-11-19T05:00:00Z   2025-11-19T19:28:14Z   0 0 09000064b9088681

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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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