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withdrawn,object_id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-0421-0002,FDA,FDA-2025-N-0421,Oscar Bobo: Final Debarment Order,Notice,Statutory Debarment,2026-05-15T04:00:00Z,2026,5,2026-05-15T04:00:00Z,,2026-05-15T17:48:54Z,2026-09767,1,0,09000064b92da9bd
FDA-2026-N-4126-0001,FDA,FDA-2026-N-4126,Azodicarbonamide (ADA); Request for Information,Notice,Requests for Information (RFI),2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,2026-07-14T03:59:59Z,2026-05-13T17:13:38Z,2026-09508,1,0,09000064b92d17fd
FDA-2026-N-3098-0001,FDA,FDA-2026-N-3098,Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting,Notice,60 Day Proposed Information Collection,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,2026-07-14T03:59:59Z,2026-05-13T16:56:28Z,2026-09543,1,0,09000064b92d4966
FDA-2026-N-2526-0001,FDA,FDA-2026-N-2526,Butylated Hydroxytoluene (BHT); Request for Information,Notice,Requests for Information (RFI),2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,2026-07-14T03:59:59Z,2026-05-13T17:01:00Z,2026-09507,1,0,09000064b92d4931
FDA-2019-N-0994-0230,FDA,FDA-2019-N-0994,"Modified Risk Tobacco Product Application: Renewal Applications for
VLN® King and VLN® Menthol King, Cigarette Products Submitted by 22nd Century Group Inc.",Notice,Request for Comments,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-15T09:00:24Z,2026-09544,1,0,09000064b92d47df
FDA-2025-N-1600-0003,FDA,FDA-2025-N-1600,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; The Real Cost Campaign Outcomes Evaluation Study: Cohort 3,Notice,30 Day Proposed Information Collection,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,2026-06-13T03:59:59Z,2026-05-13T17:17:21Z,2026-09448,1,0,09000064b92d4828
FDA-2026-N-0005-0001,FDA,FDA-2026-N-0005,Biomarker Incubator: Urinary Kidney Safety Biomarkers; Request for Information,Notice,Requests for Information (RFI),2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,2026-07-14T03:59:59Z,2026-05-13T17:06:21Z,2026-09533,1,0,09000064b92d48f3
FDA-2026-N-4492-0001,FDA,FDA-2026-N-4492,Drug Repurposing for Unmet Medical Needs; Request for Information,Notice,Requests for Information (RFI),2026-05-12T04:00:00Z,2026,5,2026-05-12T04:00:00Z,2026-06-12T03:59:59Z,2026-05-15T09:00:24Z,2026-09366,1,0,09000064b92d15f4
FDA-2017-N-5925-0040,FDA,FDA-2017-N-5925,21st Century Cures Act: Annual Compilation of Notices of Updates From the Susceptibility Test Interpretive Criteria web page,Notice,Request for Comments,2026-05-12T04:00:00Z,2026,5,2026-05-12T04:00:00Z,,2026-05-12T22:58:36Z,2026-09438,1,0,09000064b92d17af
FDA-2026-D-5083-0001,FDA,FDA-2026-D-5083,Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization; Guidance for Industry; Availability,Notice,Notice of Availability,2026-05-12T04:00:00Z,2026,5,2026-05-12T04:00:00Z,,2026-05-12T17:17:05Z,2026-09368,0,0,09000064b92d1762
FDA-2025-N-2220-0002,FDA,FDA-2025-N-2220,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications On Medical Devices and Radiation-Emitting Products,Notice,30 Day Proposed Information Collection,2026-05-11T04:00:00Z,2026,5,2026-05-11T04:00:00Z,2026-06-11T03:59:59Z,2026-05-11T21:25:31Z,2026-09244,1,0,09000064b92cfa18
FDA-2011-N-0655-0042,FDA,FDA-2011-N-0655,"Animal Generic Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Generic Drug User Fee Act Reauthorization; Request for
Notification of Stakeholder Intent To Participate",Notice,Notice of Intent,2026-05-11T04:00:00Z,2026,5,2026-05-11T04:00:00Z,,2026-05-11T21:26:21Z,2026-09284,0,0,09000064b92cf91b
FDA-2026-N-4573-0001,FDA,FDA-2026-N-4573,Issuance of Priority Review Voucher; Rare Pediatric Disease Product; AVLAYAH (tividenofusp alfa-eknm),Notice,Announcement,2026-05-11T04:00:00Z,2026,5,2026-05-11T04:00:00Z,,2026-05-11T17:34:15Z,2026-09242,0,0,09000064b92cf987
FDA-2013-D-1319-0015,FDA,FDA-2013-D-1319,Pulmonary Tuberculosis: Developing Drugs for Treatment; Guidance for Industry; Availability,Notice,Notice of Availability,2026-05-11T04:00:00Z,2026,5,2026-05-11T04:00:00Z,,2026-05-11T17:27:37Z,2026-09269,0,0,09000064b92cf98a
FDA-2018-D-4693-0022,FDA,FDA-2018-D-4693,Postapproval Pregnancy Safety Studies; Guidance for Industry; Availability,Notice,Notice of Availability,2026-05-11T04:00:00Z,2026,5,2026-05-11T04:00:00Z,,2026-05-11T17:36:17Z,2026-09268,0,0,09000064b92cf982
FDA-2011-N-0656-1315,FDA,FDA-2011-N-0656,"Animal Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Drug User Fee Act Reauthorization; Request for Notification of Stakeholder
Intent To Participate",Notice,General Notice,2026-05-11T04:00:00Z,2026,5,2026-05-11T04:00:00Z,,2026-05-11T17:56:32Z,2026-09283,0,0,09000064b92cacd0
FDA-2022-D-1261-0003,FDA,FDA-2022-D-1261,"Clostridioides Difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, or Prevention; Guidance for Industry; Availability",Notice,Notice of Availability,2026-05-11T04:00:00Z,2026,5,2026-05-11T04:00:00Z,,2026-05-11T17:42:11Z,2026-09267,0,0,09000064b92cf922
FDA-2026-P-0749-0004,FDA,FDA-2026-P-0749,"Determination That Leucovorin Calcium, Oral Solution, Equivalent to 60 Milligrams Base/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness",Notice,Determinations,2026-05-08T04:00:00Z,2026,5,,,2026-05-08T17:04:13Z,2026-09199,0,0,09000064b92c97d0
FDA-2025-P-7054-0006,FDA,FDA-2025-P-7054,"Determination That MICARDIS (Telmisartan), Tablets, 20 Milligrams and 80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness",Notice,Determinations,2026-05-07T04:00:00Z,2026,5,2026-05-07T04:00:00Z,,2026-05-07T17:15:35Z,2026-09011,0,0,09000064b92c66bf
FDA-2023-D-2370-0007,FDA,FDA-2023-D-2370,Patient-Matched Guides for Orthopedic Implants; Guidance for Industry and Food and Drug Administration Staff; Availability,Notice,Notice of Availability,2026-05-07T04:00:00Z,2026,5,2026-05-07T04:00:00Z,,2026-05-07T17:05:32Z,2026-09023,0,0,09000064b92c78fc
FDA-2026-N-4291-0001,FDA,FDA-2026-N-4291,"Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications",Notice,Withdrawal,2026-05-07T04:00:00Z,2026,5,2026-05-07T04:00:00Z,,2026-05-07T16:54:25Z,2026-09012,0,0,09000064b92c85aa
FDA-2026-N-0008-0004,FDA,FDA-2026-N-0008,Advisory Committee; Blood Products Advisory Committee; Renewal,Notice,Notice of Renewal,2026-05-07T04:00:00Z,2026,5,2026-05-07T04:00:00Z,,2026-05-07T17:02:15Z,2026-09108,0,0,09000064b92c85a3
FDA-2026-N-4588-0001,FDA,FDA-2026-N-4588,Issuance of Priority Review Voucher; Rare Pediatric Disease Product; OTARMENI (lunsotogene parvec-cwha),Notice,Announcement,2026-05-06T04:00:00Z,2026,5,2026-05-06T04:00:00Z,,2026-05-06T17:40:41Z,2026-08913,0,0,09000064b92c5bca
FDA-2026-P-1306-0004,FDA,FDA-2026-P-1306,"Determination That DEXAMETHASONE (Dexamethasone) Elixir, 0.5 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness",Notice,Determinations,2026-05-06T04:00:00Z,2026,5,2026-05-06T04:00:00Z,,2026-05-06T17:34:01Z,2026-08939,0,0,09000064b92c65a4
FDA-2026-N-3070-0001,FDA,FDA-2026-N-3070,Agency Information Collection Activities; Proposed Collection; Comment Request; National Youth Tobacco Survey,Notice,60 Day Proposed Information Collection,2026-05-04T04:00:00Z,2026,5,2026-05-04T04:00:00Z,2026-07-07T03:59:59Z,2026-05-04T19:19:25Z,2026-08604,1,0,09000064b92c115c
FDA-2018-N-3240-0377,FDA,FDA-2018-N-3240,"List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act",Notice,Request for Comments,2026-05-01T04:00:00Z,2026,5,2026-05-01T04:00:00Z,2026-07-01T03:59:59Z,2026-05-16T09:00:17Z,2026-08552,1,0,09000064b92bb724
FDA-2026-N-3499-0001,FDA,FDA-2026-N-3499,Obesity and Drug Dosing: Clinical Pharmacology Considerations; Request for Comments,Notice,Request for Comments,2026-05-01T04:00:00Z,2026,5,2026-05-01T04:00:00Z,2026-07-01T03:59:59Z,2026-05-02T09:00:17Z,2026-08521,1,0,09000064b92bb7fb
FDA-2026-N-3947-0001,FDA,FDA-2026-N-3947,Impacts of Patient-Focused Drug Development Meetings; Establishment of a Public Docket; Request for Information and Comments,Notice,Request for Comments,2026-05-01T04:00:00Z,2026,5,2026-05-01T04:00:00Z,2026-07-01T03:59:59Z,2026-05-09T09:00:22Z,2026-08524,1,0,09000064b92bb6d7
FDA-2026-N-4268-0001,FDA,FDA-2026-N-4268,Medical Devices; Exemptions From Premarket Notification: Certain Class II Devices; Request for Comments,Notice,Request for Comments,2026-05-01T04:00:00Z,2026,5,2026-05-01T04:00:00Z,2026-07-01T03:59:59Z,2026-05-09T09:00:22Z,2026-08499,1,0,09000064b92bb7b3
FDA-2026-P-0655-0003,FDA,FDA-2026-P-0655,"Determination FENOGLIDE (Fenofibrate) Tablets, 40 Milligrams and 120 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness",Notice,Determinations,2026-04-30T04:00:00Z,2026,4,,,2026-04-30T17:56:39Z,2026-08390,0,0,09000064b92b7f6c
FDA-2026-N-0499-0002,FDA,FDA-2026-N-0499,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice,Notice,30 Day Proposed Information Collection,2026-04-30T04:00:00Z,2026,4,2026-04-30T04:00:00Z,2026-06-02T03:59:59Z,2026-04-30T17:46:42Z,2026-08417,1,0,09000064b92b80f2
FDA-2026-N-0008-0003,FDA,FDA-2026-N-0008,Advisory Committee; Pharmacy Compounding Advisory Committee; Renewal,Notice,Notice of Renewal,2026-04-30T04:00:00Z,2026,4,,,2026-04-30T18:03:08Z,2026-08378,0,0,09000064b92b7f20
FDA-2025-P-3849-0004,FDA,FDA-2025-P-3849,"Determination That OZEMPIC (Semaglutide) Solution, 2 Milligrams Per 1.5 Milliliters Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness",Notice,Determinations,2026-04-30T04:00:00Z,2026,4,,,2026-04-30T18:12:42Z,2026-08435,0,0,09000064b92b5df8
FDA-2026-N-3532-0001,FDA,FDA-2026-N-3532,Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Requirements for Nonclinical Laboratory Studies,Notice,60 Day Proposed Information Collection,2026-04-30T04:00:00Z,2026,4,2026-04-30T04:00:00Z,2026-06-30T03:59:59Z,2026-05-02T09:00:17Z,2026-08371,1,0,09000064b92b7fb3
FDA-2026-N-1321-0001,FDA,FDA-2026-N-1321,"ChemoCentryx, Inc.; Proposal To Withdraw Approval of New Drug Application for TAVNEOS (Avacopan) Capsule, 10 Milligrams; Opportunity for a Hearing",Notice,Withdrawal,2026-04-30T04:00:00Z,2026,4,2026-04-30T04:00:00Z,2026-06-30T03:59:59Z,2026-05-16T09:00:16Z,2026-08455,1,0,09000064b92b7e81
FDA-2026-N-4390-0001,FDA,FDA-2026-N-4390,AI-Enabled Optimization of Early- Phase Clinical Trials Pilot Program; Request for Information,Notice,Requests for Information (RFI),2026-04-29T04:00:00Z,2026,4,2026-04-29T04:00:00Z,2026-05-30T03:59:59Z,2026-05-16T12:32:04Z,2026-08281,1,0,09000064b92b54c8
FDA-2026-N-1832-0014,FDA,FDA-2026-N-1832,GRAS Notice (GRN) 1303 - Bifidobacterium animalis subsp. lactis CGMCC5470,Notice,General Notice,2026-04-28T04:00:00Z,2026,4,2026-04-28T04:00:00Z,,2026-04-28T16:29:48Z,,0,0,09000064b92a8cd6
FDA-2025-N-1928-0067,FDA,FDA-2025-N-1928,GRAS Notice (GRN) 1279 – Saccharomyces cerevisiae CCTCC M2025194 – amendments,Notice,General Notice,2026-04-28T04:00:00Z,2026,4,2026-04-28T04:00:00Z,,2026-04-28T16:24:49Z,,0,0,09000064b92a80fa
FDA-2026-N-1832-0008,FDA,FDA-2026-N-1832,GRAS Notice (GRN) 1297 - Enzyme-hydrolyzed brown rice protein - Part 3 of 3,Notice,General Notice,2026-04-28T04:00:00Z,2026,4,2026-04-28T04:00:00Z,,2026-04-28T16:28:45Z,,0,0,09000064b92a8ccc
FDA-2025-N-1928-0066,FDA,FDA-2025-N-1928,GRAS Notice (GRN) 1278 – Lactiplantibacillus plantarum CGMCC 6312 – amendments,Notice,General Notice,2026-04-28T04:00:00Z,2026,4,2026-04-28T04:00:00Z,,2026-04-28T16:24:47Z,,0,0,09000064b92a80f9
FDA-2025-N-1928-0064,FDA,FDA-2025-N-1928,GRAS Notice (GRN) 1256 – Lemna leaf protein – amendments,Notice,General Notice,2026-04-28T04:00:00Z,2026,4,2026-04-28T04:00:00Z,,2026-04-28T16:18:46Z,,0,0,09000064b92a80f7
FDA-2026-N-1832-0007,FDA,FDA-2026-N-1832,GRAS Notice (GRN) 1297 - Enzyme-hydrolyzed brown rice protein - Part 2 of 3,Notice,General Notice,2026-04-28T04:00:00Z,2026,4,2026-04-28T04:00:00Z,,2026-04-28T16:28:26Z,,0,0,09000064b92a8ccb
FDA-2025-N-1928-0065,FDA,FDA-2025-N-1928,GRAS Notice (GRN) 1276 – Cellulase enzyme preparation produced by Trichoderma reesei expressing a gene encoding a cellulase from Aspergillus niger – amendments,Notice,General Notice,2026-04-28T04:00:00Z,2026,4,2026-04-28T04:00:00Z,,2026-04-28T16:24:37Z,,0,0,09000064b92a80f8
FDA-2026-N-1832-0015,FDA,FDA-2026-N-1832,GRAS Notice (GRN) 1304 - Preparation containing at least three bacteriophages (phage) specific to Listeria spp.,Notice,General Notice,2026-04-28T04:00:00Z,2026,4,2026-04-28T04:00:00Z,,2026-04-28T16:29:52Z,,0,0,09000064b92a8cd7
FDA-2026-N-1832-0003,FDA,FDA-2026-N-1832,GRAS Notice (GRN) 1293 - Brazzein preparation produced by Komagataella phaffii “RA-b” expressing a gene encoding for brazzein from Pentadiplandra brazzeana - Part 2 of 2,Notice,General Notice,2026-04-28T04:00:00Z,2026,4,2026-04-28T04:00:00Z,,2026-04-28T16:27:02Z,,0,0,09000064b92a8cc6
FDA-2026-N-1832-0005,FDA,FDA-2026-N-1832,GRAS Notice (GRN) 1295 - Brazzein preparation produced by Komagataella phaffii GS115 expressing a gene encoding for brazzein from Pentadiplandra brazzeana,Notice,General Notice,2026-04-28T04:00:00Z,2026,4,2026-04-28T04:00:00Z,,2026-04-28T16:27:45Z,,0,0,09000064b92a8cc9
FDA-2025-N-1928-0069,FDA,FDA-2025-N-1928,GRAS Notice (GRN) 1296 - Erythritol produced through fermentation of glucose by Yarrowia lipolytica,Notice,General Notice,2026-04-28T04:00:00Z,2026,4,2026-04-28T04:00:00Z,,2026-04-28T16:25:01Z,,0,0,09000064b92a80fc
FDA-2025-N-1928-0068,FDA,FDA-2025-N-1928,GRAS Notice (GRN) 1292 - Citrus-derived compounded sweetener made with neohesperidin dihydrochalcone and gamma cyclodextrin,Notice,General Notice,2026-04-28T04:00:00Z,2026,4,2026-04-28T04:00:00Z,,2026-04-28T16:24:59Z,,0,0,09000064b92a80fb
FDA-2026-N-1832-0010,FDA,FDA-2026-N-1832,GRAS Notice (GRN) 1299 - 3'-Sialyllactose (3'-SL) Sodium Salt,Notice,General Notice,2026-04-28T04:00:00Z,2026,4,2026-04-28T04:00:00Z,,2026-04-28T16:29:24Z,,0,0,09000064b92a8ccf
FDA-2026-N-1832-0006,FDA,FDA-2026-N-1832,GRAS Notice (GRN) 1297 - Enzyme-hydrolyzed brown rice protein - Part 1 of 3,Notice,General Notice,2026-04-28T04:00:00Z,2026,4,2026-04-28T04:00:00Z,,2026-04-28T16:27:58Z,,0,0,09000064b92a8cca
FDA-2026-N-1832-0012,FDA,FDA-2026-N-1832,GRAS Notice (GRN) 1301 - Algal oil (≥45% docosahexaenoic acid from Schizochytrium sp. “JDW-108”),Notice,General Notice,2026-04-28T04:00:00Z,2026,4,2026-04-28T04:00:00Z,,2026-04-28T16:29:36Z,,0,0,09000064b92a8cd4
FDA-2026-N-1832-0002,FDA,FDA-2026-N-1832,GRAS Notice (GRN) 1293 - Brazzein preparation produced by Komagataella phaffii “RA-b” expressing a gene encoding for brazzein from Pentadiplandra brazzeana - Part 1 of 2,Notice,General Notice,2026-04-28T04:00:00Z,2026,4,2026-04-28T04:00:00Z,,2026-04-28T16:26:49Z,,0,0,09000064b92a8cc5
FDA-2026-N-1832-0004,FDA,FDA-2026-N-1832,GRAS Notice (GRN) 1294 - Rebaudioside M produced by enzymatic treatment of steviol glycosides purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni,Notice,General Notice,2026-04-28T04:00:00Z,2026,4,2026-04-28T04:00:00Z,,2026-04-28T16:27:15Z,,0,0,09000064b92a8cc7
FDA-2026-N-1832-0009,FDA,FDA-2026-N-1832,GRAS Notice (GRN) 1298 - 2'-fucosyllactose,Notice,General Notice,2026-04-28T04:00:00Z,2026,4,2026-04-28T04:00:00Z,,2026-04-28T16:29:07Z,,0,0,09000064b92a8ccd
FDA-2026-N-1832-0013,FDA,FDA-2026-N-1832,GRAS Notice (GRN) 1302 - Fermented grape pomace,Notice,General Notice,2026-04-28T04:00:00Z,2026,4,2026-04-28T04:00:00Z,,2026-04-28T16:29:44Z,,0,0,09000064b92a8cd5
FDA-2026-N-1832-0001,FDA,FDA-2026-N-1832,GRAS Notice (GRN) 1291 - Wattle Seeds (Acacia longifolia),Notice,General Notice,2026-04-28T04:00:00Z,2026,4,2026-04-28T04:00:00Z,,2026-04-28T16:26:31Z,,0,0,09000064b92a8cc4
FDA-2026-N-1832-0011,FDA,FDA-2026-N-1832,GRAS Notice (GRN) 1300 – Zeaxanthin,Notice,General Notice,2026-04-28T04:00:00Z,2026,4,2026-04-28T04:00:00Z,,2026-04-28T16:29:32Z,,0,0,09000064b92a8cd1
FDA-2022-N-0621-0003,FDA,FDA-2022-N-0621,Advisory Committee; Anesthetic and Analgesic Drug Products Advisory Committee; Renewal,Notice,Renewals,2026-04-27T04:00:00Z,2026,4,,,2026-04-27T17:18:57Z,2026-08125,0,0,09000064b92ad1da
FDA-2026-N-3962-0001,FDA,FDA-2026-N-3962,"Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—
United States (U.S.) 2026–2027 Formula for COVID–19 Vaccine Composition",Notice,Request for Comments,2026-04-27T04:00:00Z,2026,4,2026-04-27T04:00:00Z,2026-05-28T03:59:59Z,2026-05-16T09:00:16Z,2026-08122,1,0,09000064b92ad21d
FDA-2026-N-3445-0001,FDA,FDA-2026-N-3445,"Egis Pharmaceuticals Limited, et al.; Withdrawal of Approval of Three Abbreviated New Drug Applications",Notice,Withdrawal,2026-04-24T04:00:00Z,2026,4,2026-04-24T04:00:00Z,,2026-04-24T18:50:43Z,2026-08020,0,0,09000064b92a8517
FDA-2026-N-3334-0001,FDA,FDA-2026-N-3334,"Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and
Commitments; Availability",Notice,Announcement,2026-04-24T04:00:00Z,2026,4,2026-04-24T04:00:00Z,,2026-04-24T18:41:49Z,2026-08084,0,0,09000064b92a8592
FDA-2026-N-2642-0001,FDA,FDA-2026-N-2642,Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke; Established List Additions and Request for Comments,Notice,Request for Comments,2026-04-23T04:00:00Z,2026,4,2026-04-23T04:00:00Z,2026-05-27T03:59:59Z,2026-05-16T09:00:16Z,2026-07910,1,0,09000064b92a4e3b
FDA-2025-N-7055-0002,FDA,FDA-2025-N-7055,Kimberly Schaff Kiehl: Final Debarment Order,Notice,Statutory Debarment,2026-04-23T04:00:00Z,2026,4,2026-04-23T04:00:00Z,,2026-04-24T19:52:58Z,2026-07864,1,0,09000064b92a4e3c
FDA-2026-N-2366-0010,FDA,FDA-2026-N-2366,Commissioner’s National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for Comments; Amendment,Notice,Request for Comments,2026-04-23T04:00:00Z,2026,4,2026-04-23T04:00:00Z,,2026-04-23T17:36:23Z,2026-07916,0,0,09000064b92a4d6f
FDA-2025-D-6130-0001,FDA,FDA-2025-D-6130,Establishing Impurity Specifications for Antibiotics; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2026-04-20T04:00:00Z,2026,4,2026-04-20T04:00:00Z,,2026-04-20T17:35:59Z,2026-07629,0,0,09000064b9293df3
FDA-2025-D-7121-0001,FDA,FDA-2025-D-7121,"Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators; Draft Guidance for Industry and Food and Drug
Administration Staff; Availability",Notice,Notice of Availability,2026-04-20T04:00:00Z,2026,4,2026-04-20T04:00:00Z,,2026-04-20T17:40:49Z,2026-07613,0,0,09000064b929309a
FDA-2025-N-6743-2002,FDA,FDA-2025-N-6743,Potential New Indication for Testosterone Replacement Therapy,Notice,Announcement,2026-04-20T04:00:00Z,2026,4,2026-04-20T04:00:00Z,,2026-04-20T17:25:47Z,2026-07615,0,0,09000064b9293dfa
FDA-2026-N-2917-0001,FDA,FDA-2026-N-2917,"Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed",Notice,60 Day Proposed Information Collection,2026-04-17T04:00:00Z,2026,4,2026-04-17T04:00:00Z,2026-06-17T03:59:59Z,2026-04-17T16:47:09Z,2026-07501,1,0,09000064b9289353
FDA-2011-N-0655-0041,FDA,FDA-2011-N-0655,Animal Generic Drug User Fee Act; Public Meeting; Request for Comments,Notice,Request for Comments,2026-04-17T04:00:00Z,2026,4,2026-04-17T04:00:00Z,2027-12-02T04:59:59Z,2026-04-17T17:16:13Z,2026-07497,1,0,09000064b928930a
FDA-2011-N-0656-1314,FDA,FDA-2011-N-0656,Animal Drug User Fee Act; Public Meeting; Request for Comments,Notice,Request for Comments,2026-04-17T04:00:00Z,2026,4,2026-04-17T04:00:00Z,2027-12-02T04:59:59Z,2026-04-17T17:15:38Z,2026-07498,1,0,09000064b928948d
FDA-2026-N-3099-0001,FDA,FDA-2026-N-3099,Agency Information Collection Activities; Proposed Collection; Comment Request; Radioactive Drug Research Committees,Notice,60 Day Proposed Information Collection,2026-04-17T04:00:00Z,2026,4,2026-04-17T04:00:00Z,2026-06-17T03:59:59Z,2026-04-17T16:55:18Z,2026-07507,1,0,09000064b9289303
FDA-2026-N-3799-0001,FDA,FDA-2026-N-3799,Authorization of Emergency Use for Four Animal Drugs for the Treatment of New World Screwworm; Availability,Notice,Announcement,2026-04-17T04:00:00Z,2026,4,2026-04-17T04:00:00Z,,2026-04-17T16:43:08Z,2026-07509,0,0,09000064b928935b
FDA-2025-E-0501-0006,FDA,FDA-2025-E-0501,Determination of Regulatory Review Period for Purposes of Patent Extension; UNLOXCYT,Notice,Determinations,2026-04-16T04:00:00Z,2026,4,2026-04-16T04:00:00Z,2026-06-16T03:59:59Z,2026-04-16T17:49:56Z,2026-07422,1,0,09000064b928671f
FDA-2025-E-0502-0006,FDA,FDA-2025-E-0502,Determination of Regulatory Review Period for Purposes of Patent Extension; UNLOXCYT,Notice,Determinations,2026-04-16T04:00:00Z,2026,4,2026-04-16T04:00:00Z,2026-06-16T03:59:59Z,2026-04-16T17:53:26Z,2026-07422,1,0,09000064b9286364
FDA-2026-N-3400-0001,FDA,FDA-2026-N-3400,Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs,Notice,60 Day Proposed Information Collection,2026-04-16T04:00:00Z,2026,4,2026-04-16T04:00:00Z,2026-06-16T03:59:59Z,2026-04-18T09:00:22Z,2026-07423,1,0,09000064b9286561
FDA-2025-N-6895-0001,FDA,FDA-2025-N-6895,Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List,Notice,Request for Comments,2026-04-16T04:00:00Z,2026,4,2026-04-16T04:00:00Z,2026-07-23T03:59:59Z,2026-05-15T09:00:20Z,2026-07361,1,0,09000064b92865ab
FDA-2021-D-0613-0002,FDA,FDA-2021-D-0613,"International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Stability Testing for Medicated
Premixes (Revision 1); Draft Guidance for Industry; Availability",Notice,Notice of Availability,2026-04-16T04:00:00Z,2026,4,,,2026-04-16T18:45:04Z,2026-07419,0,0,09000064b9286528
FDA-2026-N-3466-0001,FDA,FDA-2026-N-3466,Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; MRESVIA (Respiratory Syncytial Virus Vaccine),Notice,Notice of Approval,2026-04-16T04:00:00Z,2026,4,,,2026-04-16T18:40:24Z,2026-07370,0,0,09000064b9286529
FDA-2025-P-4154-0004,FDA,FDA-2025-P-4154,"Determination That CHEWTADZY (Tadalafil) Chewable Tablets, 5 Milligrams, 10 Milligrams, 20 Milligrams, Were Not Withdrawn From
Sale for Reasons of Safety or Effectiveness",Notice,Determinations,2026-04-16T04:00:00Z,2026,4,,,2026-04-16T17:43:18Z,2026-07443,0,0,09000064b92867ad
FDA-2026-N-3500-0001,FDA,FDA-2026-N-3500,Notice of Approval of Product Under Priority Review Voucher; Material Threat Medical Countermeasure Priority Review Voucher; MRESVIA (Respiratory Syncytial Virus Vaccine),Notice,Notice of Approval,2026-04-16T04:00:00Z,2026,4,,,2026-04-16T17:45:21Z,2026-07369,0,0,09000064b9286771
FDA-2026-N-3240-0001,FDA,FDA-2026-N-3240,Agency Information Collection Activities; Proposed Collection; Comment Request; Importation of Prescription Drugs,Notice,60 Day Proposed Information Collection,2026-04-16T04:00:00Z,2026,4,2026-04-16T04:00:00Z,2026-06-16T03:59:59Z,2026-04-16T18:04:30Z,2026-07421,1,0,09000064b92866e7
FDA-2025-P-4151-0004,FDA,FDA-2025-P-4151,"Determination That REVIA (Naltrexone Hydrochloride) Tablets, 50 Milligrams Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness",Notice,Determinations,2026-04-16T04:00:00Z,2026,4,,,2026-04-16T18:24:57Z,2026-07451,0,0,09000064b928652f
FDA-2026-N-3446-0001,FDA,FDA-2026-N-3446,"Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted)",Notice,Notice of Approval,2026-04-16T04:00:00Z,2026,4,,,2026-04-16T18:19:33Z,2026-07368,0,0,09000064b9286565
FDA-2026-N-3447-0001,FDA,FDA-2026-N-3447,"Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; MNEXSPIKE (COVID–19 Vaccine, mRNA)",Notice,Notice of Approval,2026-04-16T04:00:00Z,2026,4,,,2026-04-16T18:06:41Z,2026-07371,0,0,09000064b92866e5
FDA-2026-D-1255-0001,FDA,FDA-2026-D-1255,Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2026-04-15T04:00:00Z,2026,4,2026-04-15T04:00:00Z,,2026-04-15T17:11:56Z,2026-07285,0,0,09000064b92810b1
FDA-2025-N-4731-0052,FDA,FDA-2025-N-4731,Increasing Access to Nonprescription Drugs; Public Meeting; Request for Comments,Notice,Request for Comments,2026-04-15T04:00:00Z,2026,4,2026-04-23T04:00:00Z,2026-05-09T03:59:59Z,2026-05-09T09:00:20Z,2026-07335,0,0,09000064b9282192
FDA-2026-N-3273-0001,FDA,FDA-2026-N-3273,"Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; Public Meeting; Request for Comments",Notice,Request for Comments,2026-04-15T04:00:00Z,2026,4,2026-04-15T04:00:00Z,2026-07-24T03:59:59Z,2026-04-15T17:05:22Z,2026-07248,1,0,09000064b9282224
FDA-2025-P-2524-0004,FDA,FDA-2025-P-2524,"Determination That BILTRICIDE (Praziquantel) Oral Tablet, 600 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness",Notice,Determinations,2026-04-13T04:00:00Z,2026,4,2026-04-13T04:00:00Z,,2026-04-13T21:09:10Z,2026-07059,0,0,09000064b9272b56
FDA-2026-N-0707-0001,FDA,FDA-2026-N-0707,"GlaxoSmithKline; Withdrawal of Approval of a New Drug Application for Wellcovorin (Leucovorin Calcium) Tablets, EQ 5 mg Base and EQ 25 mg Base",Notice,Withdrawal,2026-04-10T04:00:00Z,2026,4,2026-04-10T04:00:00Z,,2026-04-10T17:40:29Z,2026-06911,0,0,09000064b926837d
FDA-2026-N-2742-0001,FDA,FDA-2026-N-2742,Agency Information Collection Activities; Proposed Collection; Comment Request; Color Additive Certification,Notice,60 Day Proposed Information Collection,2026-04-10T04:00:00Z,2026,4,2026-04-10T04:00:00Z,2026-06-10T03:59:59Z,2026-04-10T18:01:37Z,2026-06936,1,0,09000064b926825a
FDA-2026-N-2743-0001,FDA,FDA-2026-N-2743,"Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503",Notice,60 Day Proposed Information Collection,2026-04-10T04:00:00Z,2026,4,2026-04-10T04:00:00Z,2026-06-10T03:59:59Z,2026-04-20T09:00:32Z,2026-06935,1,0,09000064b926821b
FDA-2026-N-2915-0001,FDA,FDA-2026-N-2915,Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices,Notice,60 Day Proposed Information Collection,2026-04-10T04:00:00Z,2026,4,2026-04-10T04:00:00Z,2026-06-10T03:59:59Z,2026-04-10T17:47:50Z,2026-06906,1,0,09000064b9268328
FDA-2025-N-1928-0061,FDA,FDA-2025-N-1928,GRAS Notice (GRN) 1283 - Bacillus coagulans BC99 spore preparation - amendment,Notice,General Notice,2026-04-08T04:00:00Z,2026,4,2026-04-08T04:00:00Z,,2026-04-08T18:16:57Z,,0,0,09000064b925c73b
FDA-2025-N-1928-0063,FDA,FDA-2025-N-1928,GRAS Notice (GRN) 1287 - Sucrose oligoesters - amendments,Notice,General Notice,2026-04-08T04:00:00Z,2026,4,2026-04-08T04:00:00Z,,2026-04-08T18:17:22Z,,0,0,09000064b925c73d
FDA-2025-N-1928-0058,FDA,FDA-2025-N-1928,GRAS Notice (GRN) 1266 - Wheat fiber extract from wheat (Triticumaestivum) - amendments,Notice,General Notice,2026-04-08T04:00:00Z,2026,4,2026-04-08T04:00:00Z,,2026-04-08T18:16:16Z,,0,0,09000064b925c737
FDA-2025-N-1928-0059,FDA,FDA-2025-N-1928,GRAS Notice (GRN) 1271 - Short Chain Fructooligosaccharides - amendments,Notice,General Notice,2026-04-08T04:00:00Z,2026,4,2026-04-08T04:00:00Z,,2026-04-08T18:16:28Z,,0,0,09000064b925c738
FDA-2025-N-1928-0060,FDA,FDA-2025-N-1928,GRAS Notice (GRN) 1275 - 6'-Sialyllactose sodium salt - amendments,Notice,General Notice,2026-04-08T04:00:00Z,2026,4,2026-04-08T04:00:00Z,,2026-04-08T18:16:42Z,,0,0,09000064b925c73a
FDA-2025-N-1928-0062,FDA,FDA-2025-N-1928,GRAS Notice (GRN) 1284 - Recombinant bovine lactoferrin isolate produced by Komagataella phaffii “Ppas_337” expressing the gene encoding bovine lactoferrin – amendments,Notice,General Notice,2026-04-08T04:00:00Z,2026,4,2026-04-08T04:00:00Z,,2026-04-08T18:17:10Z,,0,0,09000064b925c73c
FDA-2026-N-3058-0001,FDA,FDA-2026-N-3058,Issuance of Priority Review Voucher; Rare Pediatric Disease Product; LOARGYS (pegzilarginase-nbln),Notice,Announcement,2026-04-07T04:00:00Z,2026,4,2026-04-07T04:00:00Z,,2026-04-07T18:06:33Z,2026-06722,0,0,09000064b9256d79
FDA-2026-N-2431-0001,FDA,FDA-2026-N-2431,Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Practices and Procedures; Formal Hearings,Notice,60 Day Proposed Information Collection,2026-04-07T04:00:00Z,2026,4,2026-04-07T04:00:00Z,2026-06-09T03:59:59Z,2026-05-12T09:00:14Z,2026-06719,1,0,09000064b9255485