{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\", document_type = \"Notice\" and posted_year = 2025 sorted by posted_date descending", "rows": [["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", null, "2025-12-30T23:09:02Z", null, 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", null, "2025-12-30T23:17:03Z", null, 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", null, "2025-12-30T23:15:50Z", null, 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", null, "2025-12-30T23:16:15Z", null, 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", null, "2025-12-30T23:12:21Z", null, 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", null, "2025-12-30T23:07:43Z", null, 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", null, "2025-12-30T23:10:03Z", null, 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", null, "2025-12-30T23:10:59Z", null, 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", null, "2025-12-30T23:15:10Z", null, 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", null, "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\u2014OTC Monograph Order Request Fee Rates for Fiscal Year 2026", "Notice", "Announcement", "2025-12-29T05:00:00Z", 2025, 12, "2025-12-29T05:00:00Z", null, "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", null, "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", null, "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", null, "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", null, "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", null, "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", null, "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", null, "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", null, "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", null, "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", null, "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", null, "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", null, "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", null, "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", null, "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", null, "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\nQLEX (pembrolizumab and berahyaluronidase alfa-pmph)", "Notice", "Notice of Approval", "2025-12-19T05:00:00Z", 2025, 12, "2025-12-19T05:00:00Z", null, "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, null, null, "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, null, null, "2025-12-18T18:30:54Z", "2025-23249", 0, 0, "09000064b90eed0c"], ["FDA-2021-D-0368-0012", "FDA", "FDA-2021-D-0368", "Investigator Responsibilities\u2014Safety 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", null, "2025-12-16T18:17:17Z", "2025-22869", 0, 0, "09000064b90da8c2"], ["FDA-2020-D-2099-0012", "FDA", "FDA-2020-D-2099", "Sponsor Responsibilities\u2014Safety Reporting Requirements and Safety Assessment for Investigational New\nDrug 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", null, "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\nSafety or Effectiveness", "Notice", "Determinations", "2025-12-12T05:00:00Z", 2025, 12, "2025-12-12T05:00:00Z", null, "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", null, "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", null, "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/\nMilliliter, 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", null, "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\nWere Not Withdrawn From Sale for Reasons of Safety or Effectiveness", "Notice", "Determinations", "2025-12-12T05:00:00Z", 2025, 12, "2025-12-12T05:00:00Z", null, "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", null, "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, null, null, "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", null, "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", null, "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\u201319 Pandemic; Availability", "Notice", "Announcement", "2025-12-08T05:00:00Z", 2025, 12, "2025-12-08T05:00:00Z", null, "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, null, null, "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", null, "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", null, "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, null, null, "2025-12-01T19:17:15Z", "2025-21702", 0, 0, "09000064b90a5cdd"], ["FDA-2024-N-3945-0008", "FDA", "FDA-2024-N-3945", "FDA\u2019s Strategy Document on Innovative Manufacturing Technologies", "Notice", "Notice of Availability", "2025-12-01T05:00:00Z", 2025, 12, "2025-12-01T05:00:00Z", null, "2025-12-04T10:00:27Z", "2025-21692", 1, 0, "09000064b90a5c2f"], ["FDA-2003-D-0431-0064", "FDA", "FDA-2003-D-0431", "Medical Gases\u2014Current 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, null, null, "2025-11-26T19:08:51Z", "2025-21224", 0, 0, "09000064b909ec11"], ["FDA-2025-N-1928-0025", "FDA", "FDA-2025-N-1928", "GRAS Notice (GRN) 1268 \u2013 Mycelial biomass", "Notice", "General Notice", "2025-11-25T05:00:00Z", 2025, 11, "2025-11-25T05:00:00Z", null, "2025-11-25T20:38:16Z", null, 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", null, "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\nMilligrams, 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", null, "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\nSYSTEM", "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\u2014Establishment of Public\nDocket; 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\nAssessment 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, null, null, "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", null, "2025-11-20T19:15:15Z", "2025-20380", 0, 0, "09000064b908a856"], ["FDA-2025-N-1928-0022", "FDA", "FDA-2025-N-1928", "GRAS Notice (GRN) 1275 \u2013 Sialyllactose sodium salt", "Notice", "General Notice", "2025-11-19T05:00:00Z", 2025, 11, "2025-11-19T05:00:00Z", null, "2025-11-19T19:29:21Z", null, 0, 0, "09000064b9088b1c"], ["FDA-2025-N-1928-0023", "FDA", "FDA-2025-N-1928", "GRAS Notice (GRN) 1277 \u2013 Parabacteroides goldsteinii", "Notice", "General Notice", "2025-11-19T05:00:00Z", 2025, 11, "2025-11-19T05:00:00Z", null, "2025-11-19T19:29:26Z", null, 0, 0, "09000064b9088b1d"], ["FDA-2025-N-1928-0024", "FDA", "FDA-2025-N-1928", "GRAS Notice (GRN) 1279 \u2013 Saccharomyces cerevisiae", "Notice", "General Notice", "2025-11-19T05:00:00Z", 2025, 11, "2025-11-19T05:00:00Z", null, "2025-11-19T19:29:33Z", null, 0, 0, "09000064b9088b28"], ["FDA-2025-N-1928-0020", "FDA", "FDA-2025-N-1928", "GRAS Notice (GRN) 1272 \u2013 Lacto-N-neotetraose", "Notice", "General Notice", "2025-11-19T05:00:00Z", 2025, 11, "2025-11-19T05:00:00Z", null, "2025-11-19T19:29:06Z", null, 0, 0, "09000064b9088b1a"], ["FDA-2025-N-1928-0021", "FDA", "FDA-2025-N-1928", "GRAS Notice (GRN) 1274 \u2013 2\u2019-Fucosyllactose", "Notice", "General Notice", "2025-11-19T05:00:00Z", 2025, 11, "2025-11-19T05:00:00Z", null, "2025-11-19T19:29:14Z", null, 0, 0, "09000064b9088b1b"], ["FDA-2025-N-1928-0015", "FDA", "FDA-2025-N-1928", "GRAS Notice (GRN) 1264 \u2013 Lacticaseibacillus rhamnosus", "Notice", "General Notice", "2025-11-19T05:00:00Z", 2025, 11, "2025-11-19T05:00:00Z", null, "2025-11-19T19:28:38Z", null, 0, 0, "09000064b9088b14"], ["FDA-2025-N-1927-0098", "FDA", "FDA-2025-N-1927", "GRAS Notice (GRN) 1232 \u2013 Lacticaseibacillus paracasei - Amendments", "Notice", "General Notice", "2025-11-19T05:00:00Z", 2025, 11, "2025-11-19T05:00:00Z", null, "2025-11-19T19:28:14Z", null, 0, 0, "09000064b9088681"]], "truncated": false, "filtered_table_rows_count": 751, "expanded_columns": [], "expandable_columns": [[{"column": "docket_id", "other_table": "dockets", "other_column": "id"}, "title"]], "columns": ["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"], "primary_keys": ["id"], "units": {}, "query": {"sql": "select 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 from documents where \"agency_id\" = :p0 and \"document_type\" = :p1 and \"posted_year\" = :p2 order by posted_date desc limit 101", "params": {"p0": "FDA", "p1": "Notice", "p2": "2025"}}, "facet_results": {"agency_id": {"name": "agency_id", "type": "column", "hideable": false, "toggle_url": "/openregs/documents.json?agency_id=FDA&document_type=Notice&posted_year=2025", "results": [{"value": "FDA", "label": "FDA", "count": 751, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?document_type=Notice&posted_year=2025", "selected": true}], "truncated": false}, "document_type": {"name": "document_type", "type": "column", "hideable": false, "toggle_url": "/openregs/documents.json?agency_id=FDA&document_type=Notice&posted_year=2025", "results": [{"value": "Notice", "label": "Notice", "count": 751, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&posted_year=2025", "selected": true}], "truncated": false}, "posted_year": {"name": "posted_year", "type": "column", "hideable": false, "toggle_url": "/openregs/documents.json?agency_id=FDA&document_type=Notice&posted_year=2025", "results": [{"value": 2025, "label": 2025, "count": 751, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&document_type=Notice", "selected": true}], "truncated": false}}, "suggested_facets": [{"name": "subtype", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&document_type=Notice&posted_year=2025&_facet=subtype"}, {"name": "posted_month", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&document_type=Notice&posted_year=2025&_facet=posted_month"}, {"name": "open_for_comment", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&document_type=Notice&posted_year=2025&_facet=open_for_comment"}, {"name": "withdrawn", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&document_type=Notice&posted_year=2025&_facet=withdrawn"}, {"name": "posted_date", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&document_type=Notice&posted_year=2025&_facet_date=posted_date"}, {"name": "comment_start_date", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&document_type=Notice&posted_year=2025&_facet_date=comment_start_date"}, {"name": "comment_end_date", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&document_type=Notice&posted_year=2025&_facet_date=comment_end_date"}, {"name": "last_modified", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&document_type=Notice&posted_year=2025&_facet_date=last_modified"}], "next": "2025-11-19T05~3A00~3A00Z,FDA-2025-N-1927-0098", "next_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&document_type=Notice&posted_year=2025&_next=2025-11-19T05~3A00~3A00Z%2CFDA-2025-N-1927-0098&_sort_desc=posted_date", "private": false, "allow_execute_sql": true, "query_ms": 469.26413700566627, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}