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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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