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withdrawn,object_id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,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