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184 rows where agency_id = "FDA" sorted by comment_end_date descending
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agency_id 1
- FDA · 184 ✖
| 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posted_year | posted_month | comment_start_date | comment_end_date ▲ | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2026-N-0131-0001 | FDA | FDA-2026-N-0131 | FDA Rare Disease Innovation Hub Future Programming; Request for Comments | Notice | Request for Comments | 2026-01-30 | 2026 | 1 | 2026-01-30 | 2027-01-01 | 2026-03-22 09:00:09 | 2026-01903 | 1 | 0 | 09000064b91893ee |
| FDA-2016-D-1280-0005 | FDA | FDA-2016-D-1280 | Electronic Submission of Postmarketing Individual Case Safety Reports to the Food and Drug Administration Adverse Event Monitoring System Using International Council of Harmonisation E2B(R3) Data Standards; Regional Data Elements and Implementation Schedule | Notice | Announcement | 2026-04-06 | 2026 | 4 | 2026-04-06 | 2026-10-02 | 2026-04-07 09:00:25 | 2026-06660 | 1 | 0 | 09000064b9253dbc |
| FDA-2025-E-2426-0006 | FDA | FDA-2025-E-2426 | Determination of Regulatory Review Period for Purposes of Patent Extension; BLUJEPA | Notice | Determinations | 2026-02-13 | 2026 | 2 | 2026-02-13 | 2026-08-13 | 2026-02-13 20:03:13 | 2026-02901 | 1 | 0 | 09000064b91aa6fb |
| FDA-2025-E-0152-0006 | FDA | FDA-2025-E-0152 | Determination of Regulatory Review Period for Purposes of Patent Extension; COBENFY | Notice | Determinations | 2026-02-06 | 2026 | 2 | 2026-02-06 | 2026-08-06 | 2026-02-06 20:05:43 | 2026-02388 | 1 | 0 | 09000064b919467e |
| FDA-2025-E-0153-0006 | FDA | FDA-2025-E-0153 | Determination of Regulatory Review Period for Purposes of Patent Extension; COBENFY | Notice | Determinations | 2026-02-06 | 2026 | 2 | 2026-02-06 | 2026-08-06 | 2026-02-06 20:06:34 | 2026-02388 | 1 | 0 | 09000064b919467f |
| FDA-2024-E-3539-0006 | FDA | FDA-2024-E-3539 | Determination of Regulatory Review Period for Purposes of Patent Extension; BEQVEZ | Notice | Determinations | 2026-02-06 | 2026 | 2 | 2026-02-06 | 2026-08-06 | 2026-02-14 13:19:52 | 2026-02387 | 1 | 0 | 09000064b9195b4d |
| FDA-2025-E-0154-0006 | FDA | FDA-2025-E-0154 | Determination of Regulatory Review Period for Purposes of Patent Extension; COBENFY | Notice | Determinations | 2026-02-06 | 2026 | 2 | 2026-02-06 | 2026-08-06 | 2026-02-06 20:07:01 | 2026-02388 | 1 | 0 | 09000064b9195c17 |
| 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 | 2026-04-15 | 2026 | 4 | 2026-04-15 | 2026-07-24 | 2026-04-15 17:05:22 | 2026-07248 | 1 | 0 | 09000064b9282224 |
| FDA-2026-P-0749-0001 | FDA | FDA-2026-P-0749 | Citizen Petition from Apotex Inc. | Other | Citizen Petition | 2026-01-26 | 2026 | 1 | 2026-01-26 | 2026-07-23 | 2026-01-27 01:08:18 | 1 | 0 | 09000064b9182c73 | |
| FDA-2026-D-1255-0002 | FDA | FDA-2026-D-1255 | Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry | Other | Guidance | 2026-04-15 | 2026 | 4 | 2026-04-15 | 2026-07-15 | 2026-04-16 09:00:16 | 1 | 0 | 09000064b9282a2a | |
| FDA-2023-N-0119-0020 | FDA | FDA-2023-N-0119 | Fiscal Year 2026 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments | Notice | Request for Comments | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-07-11 | 2026-04-14 09:00:18 | 2026-03961 | 1 | 0 | 09000064b91e326c |
| FDA-2026-N-2366-0001 | FDA | FDA-2026-N-2366 | Commissioner’s National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for Comments | Notice | Request for Comments | 2026-03-23 | 2026 | 3 | 2026-03-23 | 2026-06-30 | 2026-04-12 09:00:14 | 2026-05573 | 1 | 0 | 09000064b922c21a |
| 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 | 2026-04-10 | 2026 | 4 | 2026-04-10 | 2026-06-10 | 2026-04-10 18:01:37 | 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 | 2026-04-10 | 2026 | 4 | 2026-04-10 | 2026-06-10 | 2026-04-10 18:22:24 | 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 | 2026-04-10 | 2026 | 4 | 2026-04-10 | 2026-06-10 | 2026-04-10 17:47:50 | 2026-06906 | 1 | 0 | 09000064b9268328 |
| 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 | 2026-04-07 | 2026 | 4 | 2026-04-07 | 2026-06-09 | 2026-04-14 19:40:33 | 2026-06719 | 1 | 0 | 09000064b9255485 |
| FDA-2025-E-0863-0006 | FDA | FDA-2025-E-0863 | Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY | Notice | Determinations | 2026-04-03 | 2026 | 4 | 2026-04-03 | 2026-06-03 | 2026-04-03 17:37:03 | 2026-06478 | 1 | 0 | 09000064b924cccb |
| FDA-2025-E-0845-0006 | FDA | FDA-2025-E-0845 | Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY | Notice | Determinations | 2026-04-03 | 2026 | 4 | 2026-04-03 | 2026-06-03 | 2026-04-03 17:34:01 | 2026-06478 | 1 | 0 | 09000064b924dac3 |
| FDA-2025-E-0866-0006 | FDA | FDA-2025-E-0866 | Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY | Notice | Determinations | 2026-04-03 | 2026 | 4 | 2026-04-03 | 2026-06-03 | 2026-04-03 17:42:13 | 2026-06478 | 1 | 0 | 09000064b924ccce |
| FDA-2025-E-0372-0005 | FDA | FDA-2025-E-0372 | Determination of Regulatory Review Period for Purposes of Patent Extension; ZIIHERA | Notice | Determinations | 2026-04-03 | 2026 | 4 | 2026-04-03 | 2026-06-03 | 2026-04-03 17:52:42 | 2026-06476 | 1 | 0 | 09000064b924da88 |
| FDA-2025-E-3074-0006 | FDA | FDA-2025-E-3074 | Determination of Regulatory Review Period for Purposes of Patent Extension; EMRELIS | Notice | Determinations | 2026-04-03 | 2026 | 4 | 2026-04-03 | 2026-06-03 | 2026-04-03 17:57:30 | 2026-06480 | 1 | 0 | 09000064b924c470 |
| FDA-2025-E-0871-0006 | FDA | FDA-2025-E-0871 | Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY | Notice | Determinations | 2026-04-03 | 2026 | 4 | 2026-04-03 | 2026-06-03 | 2026-04-03 17:49:10 | 2026-06478 | 1 | 0 | 09000064b924c46e |
| FDA-2025-E-3073-0006 | FDA | FDA-2025-E-3073 | Determination of Regulatory Review Period for Purposes of Patent Extension; EMRELIS | Notice | Determinations | 2026-04-03 | 2026 | 4 | 2026-04-03 | 2026-06-03 | 2026-04-03 17:55:54 | 2026-06480 | 1 | 0 | 09000064b924da86 |
| FDA-2025-E-3626-0006 | FDA | FDA-2025-E-3626 | Determination of Regulatory Review Period for Purposes of Patent Extension; ENFLONSIA | Notice | Determinations | 2026-04-03 | 2026 | 4 | 2026-04-03 | 2026-06-03 | 2026-04-03 17:59:57 | 2026-06479 | 1 | 0 | 09000064b924d98d |
| FDA-2025-E-0870-0006 | FDA | FDA-2025-E-0870 | Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY | Notice | Determinations | 2026-04-03 | 2026 | 4 | 2026-04-03 | 2026-06-03 | 2026-04-03 17:48:07 | 2026-06478 | 1 | 0 | 09000064b924c46d |
| FDA-2026-N-2740-0001 | FDA | FDA-2026-N-2740 | Agency Information Collection Activities; Proposed Collection; Comment Request; Customer/Partner Customer Service Satisfaction Surveys | Notice | 60 Day Proposed Information Collection | 2026-04-03 | 2026 | 4 | 2026-04-03 | 2026-06-03 | 2026-04-03 17:29:44 | 2026-06482 | 1 | 0 | 09000064b924dac4 |
| FDA-2025-E-0868-0006 | FDA | FDA-2025-E-0868 | Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY | Notice | Determinations | 2026-04-03 | 2026 | 4 | 2026-04-03 | 2026-06-03 | 2026-04-03 17:44:23 | 2026-06478 | 1 | 0 | 09000064b924c0e1 |
| FDA-2025-E-0865-0006 | FDA | FDA-2025-E-0865 | Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY | Notice | Determinations | 2026-04-03 | 2026 | 4 | 2026-04-03 | 2026-06-03 | 2026-04-03 17:39:45 | 2026-06478 | 1 | 0 | 09000064b924cccd |
| FDA-2025-E-1672-0007 | FDA | FDA-2025-E-1672 | Determination of Regulatory Review Period for Purposes of Patent Extension; ENCELTO | Notice | Determinations | 2026-04-03 | 2026 | 4 | 2026-04-03 | 2026-06-03 | 2026-04-03 18:06:28 | 2026-06477 | 1 | 0 | 09000064b924d940 |
| FDA-2014-E-2328-0006 | FDA | FDA-2014-E-2328 | Determination of Regulatory Review Period for Purposes of Patent Extension; INJECTAFER | Notice | Determinations | 2026-04-03 | 2026 | 4 | 2026-04-03 | 2026-06-03 | 2026-04-03 18:09:13 | 2026-06483 | 1 | 0 | 09000064b924d4f5 |
| FDA-2025-E-0864-0006 | FDA | FDA-2025-E-0864 | Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY | Notice | Determinations | 2026-04-03 | 2026 | 4 | 2026-04-03 | 2026-06-03 | 2026-04-03 17:38:27 | 2026-06478 | 1 | 0 | 09000064b924cccc |
| FDA-2025-E-0872-0006 | FDA | FDA-2025-E-0872 | Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY | Notice | Determinations | 2026-04-03 | 2026 | 4 | 2026-04-03 | 2026-06-03 | 2026-04-03 17:50:02 | 2026-06478 | 1 | 0 | 09000064b924c46f |
| FDA-2025-E-0867-0006 | FDA | FDA-2025-E-0867 | Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY | Notice | Determinations | 2026-04-03 | 2026 | 4 | 2026-04-03 | 2026-06-03 | 2026-04-03 17:43:31 | 2026-06478 | 1 | 0 | 09000064b924c0e0 |
| FDA-2025-E-0158-0006 | FDA | FDA-2025-E-0158 | Determination of Regulatory Review Period for Purposes of Patent Extension; HYMPAVZI | Notice | Determinations | 2026-04-03 | 2026 | 4 | 2026-04-03 | 2026-06-03 | 2026-04-03 18:04:00 | 2026-06481 | 1 | 0 | 09000064b924d942 |
| FDA-2025-E-0869-0006 | FDA | FDA-2025-E-0869 | Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY | Notice | Determinations | 2026-04-03 | 2026 | 4 | 2026-04-03 | 2026-06-03 | 2026-04-03 17:45:32 | 2026-06478 | 1 | 0 | 09000064b924ba07 |
| FDA-2026-C-3071-0001 | FDA | FDA-2026-C-3071 | Filing of Color Additive Petition: International Association of Color Manufacturers; Request to Amend the Color Additive Regulations to Remove the Solvents Methylene Chloride, Trichloroethylene, and Ethylene Dichloride | Proposed Rule | Petition | 2026-04-01 | 2026 | 4 | 2026-04-01 | 2026-06-02 | 2026-04-01 17:16:12 | 2026-06295 | 1 | 0 | 09000064b9249960 |
| FDA-2026-N-0809-0001 | FDA | FDA-2026-N-0809 | Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments | Notice | Request for Comments | 2026-03-03 | 2026 | 3 | 2026-03-03 | 2026-06-02 | 2026-04-13 09:00:28 | 2026-04196 | 1 | 0 | 09000064b91ed501 |
| FDA-2026-N-2476-0001 | FDA | FDA-2026-N-2476 | Advancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products; Request for Information and Comments | Notice | Request for Comments | 2026-03-31 | 2026 | 3 | 2026-03-31 | 2026-06-02 | 2026-04-10 09:00:28 | 2026-06184 | 1 | 0 | 09000064b92439d6 |
| FDA-2026-N-2590-0001 | FDA | FDA-2026-N-2590 | Microbiology Devices; Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests | Proposed Rule | Request for Comment | 2026-03-30 | 2026 | 3 | 2026-03-30 | 2026-05-30 | 2026-04-13 09:00:30 | 2026-06064 | 1 | 0 | 09000064b92437b6 |
| 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 | 2025-11-24 | 2025 | 11 | 2025-11-24 | 2026-05-27 | 2026-01-24 13:16:48 | 2025-20667 | 1 | 0 | 09000064b908e3f0 |
| 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 | 2025-11-24 | 2025 | 11 | 2025-11-24 | 2026-05-27 | 2026-01-24 13:16:48 | 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 | 2025-11-24 | 2025 | 11 | 2025-11-24 | 2026-05-27 | 2026-01-24 13:16:50 | 2025-20667 | 1 | 0 | 09000064b9092f99 |
| 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 | 2025-11-24 | 2025 | 11 | 2025-11-24 | 2026-05-27 | 2025-11-24 19:32:14 | 2025-20668 | 1 | 0 | 09000064b9093521 |
| FDA-2026-N-2365-0001 | FDA | FDA-2026-N-2365 | Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Associated With Animal Drug and Animal Generic Drug User Fees | Notice | 60 Day Proposed Information Collection | 2026-03-23 | 2026 | 3 | 2026-03-23 | 2026-05-23 | 2026-03-23 17:37:47 | 2026-05620 | 1 | 0 | 09000064b922c25e |
| FDA-2026-N-2364-0001 | FDA | FDA-2026-N-2364 | Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Advisory Committees | Notice | 60 Day Proposed Information Collection | 2026-03-23 | 2026 | 3 | 2026-03-23 | 2026-05-23 | 2026-03-25 09:00:29 | 2026-05623 | 1 | 0 | 09000064b922c187 |
| FDA-2025-D-2837-0002 | FDA | FDA-2025-D-2837 | Questions and Answers About Requirements for Additional Traceability Records for Certain Foods: Guidance for Industry - Draft Guidance | Other | Guidance | 2026-02-20 | 2026 | 2 | 2026-02-20 | 2026-05-22 | 2026-02-20 20:47:16 | 1 | 0 | 09000064b91c9d9a | |
| FDA-2026-N-1304-0001 | FDA | FDA-2026-N-1304 | Agenda for the U.S. Food and Drug Administration (FDA) Virtual Public Meeting Food Allergen Thresholds and Their Potential Applications 2-18-2026 | Other | Agenda | 2026-02-18 | 2026 | 2 | 2026-02-18 | 2026-05-20 | 2026-04-10 09:00:23 | 1 | 0 | 09000064b91b5eeb | |
| FDA-2025-N-5996-0001 | FDA | FDA-2025-N-5996 | Medical Devices; Radiology Devices; Classification of Blood Irradiators | Proposed Rule | Notice of Proposed Rulemaking (NPRM) | 2026-03-18 | 2026 | 3 | 2026-03-18 | 2026-05-19 | 2026-03-29 09:00:14 | 2026-05320 | 1 | 0 | 09000064b92216a5 |
| FDA-2025-N-5995-0001 | FDA | FDA-2025-N-5995 | Effective Date of Requirement for Premarket Approval Applications for Blood Irradiators Intended To Prevent Metastasis | Proposed Rule | Notice of Proposed Rulemaking (NPRM) | 2026-03-18 | 2026 | 3 | 2026-03-18 | 2026-05-19 | 2026-03-21 09:00:16 | 2026-05322 | 1 | 0 | 09000064b92215cb |
| FDA-2026-N-1849-0001 | FDA | FDA-2026-N-1849 | Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notifications Submission | Notice | 60 Day Proposed Information Collection | 2026-03-19 | 2026 | 3 | 2026-03-19 | 2026-05-19 | 2026-03-19 17:24:48 | 2026-05329 | 1 | 0 | 09000064b9224334 |
| FDA-2026-N-2279-0001 | FDA | FDA-2026-N-2279 | Preparation for International Cooperation on Cosmetics Regulation Twentieth Annual Meeting (ICCR–20); Request for Comments | Notice | Request for Comments | 2026-03-18 | 2026 | 3 | 2026-03-18 | 2026-05-19 | 2026-04-03 09:00:22 | 2026-05280 | 1 | 0 | 09000064b922165c |
| FDA-2025-D-6131-0002 | FDA | FDA-2025-D-6131 | General Considerations for the Use of New Approach Methodologies in Drug Development; Guidance for Industry - Draft Guidance | Other | Guidance | 2026-03-19 | 2026 | 3 | 2026-03-19 | 2026-05-19 | 2026-04-15 09:00:24 | 1 | 0 | 09000064b9223609 | |
| FDA-2026-N-1736-0001 | FDA | FDA-2026-N-1736 | Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements | Notice | 60 Day Proposed Information Collection | 2026-03-13 | 2026 | 3 | 2026-03-13 | 2026-05-13 | 2026-03-13 17:05:05 | 2026-04938 | 1 | 0 | 09000064b92145ad |
| FDA-2026-D-1817-0002 | FDA | FDA-2026-D-1817 | Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications—Considerations Related to Youth Risk - Draft Guidance for Industry | Other | Guidance | 2026-03-11 | 2026 | 3 | 2026-03-11 | 2026-05-12 | 2026-04-14 09:00:19 | 1 | 0 | 09000064b920c96d | |
| FDA-2011-D-0611-0094 | FDA | FDA-2011-D-0611 | New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4) Guidance for Industry - Draft Guidance | Other | Guidance | 2026-03-10 | 2026 | 3 | 2026-03-10 | 2026-05-12 | 2026-03-14 09:00:14 | 1 | 0 | 09000064b92071bb | |
| FDA-2025-N-4731-0052 | FDA | FDA-2025-N-4731 | Increasing Access to Nonprescription Drugs; Public Meeting; Request for Comments | Notice | Request for Comments | 2026-04-15 | 2026 | 4 | 2026-04-15 | 2026-05-09 | 2026-04-15 17:08:45 | 2026-07335 | 1 | 0 | 09000064b9282192 |
| FDA-2025-D-1504-0002 | FDA | FDA-2025-D-1504 | Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry | Other | Guidance | 2026-03-09 | 2026 | 3 | 2026-03-09 | 2026-05-09 | 2026-04-10 09:00:26 | 1 | 0 | 09000064b9200f6d | |
| FDA-2025-E-0493-0006 | FDA | FDA-2025-E-0493 | Determination of Regulatory Review Period for Purposes of Patent Extension; ENSACOVE | Notice | Determinations | 2026-03-06 | 2026 | 3 | 2026-03-06 | 2026-05-06 | 2026-03-06 19:06:30 | 2026-04491 | 1 | 0 | 09000064b91f8458 |
| FDA-2024-D-4388-0002 | FDA | FDA-2024-D-4388 | New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers Guidance for Industry - Draft Guidance | Other | Guidance | 2026-03-04 | 2026 | 3 | 2026-03-04 | 2026-05-05 | 2026-03-09 09:00:19 | 1 | 0 | 09000064b91ef6ec | |
| FDA-2026-N-2741-0001 | FDA | FDA-2026-N-2741 | Consideration of Acceptable Market Name Change for Certain Rockfish (Sebastes spp.); Request for Information | Notice | Requests for Information (RFI) | 2026-04-01 | 2026 | 4 | 2026-04-01 | 2026-05-02 | 2026-04-14 19:40:35 | 2026-06294 | 1 | 0 | 09000064b924995a |
| FDA-2026-N-1867-0001 | FDA | FDA-2026-N-1867 | Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—New Drug Application 220359, for Camizestrant Tablets; Supplemental New Drug Application (sNDA) 218197/S–004, for Truqap (Capivasertib) Tablets | Notice | Request for Comments | 2026-03-09 | 2026 | 3 | 2026-03-09 | 2026-04-30 | 2026-04-16 09:00:12 | 2026-04497 | 1 | 0 | 09000064b9200842 |
| FDA-2007-D-0369-2444 | FDA | FDA-2007-D-0369 | PSG_020151 - Draft Guidance on Venlafaxine Hydrochloride | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:22:37 | 1 | 0 | 09000064b91df4e6 | |
| FDA-2007-D-0369-2442 | FDA | FDA-2007-D-0369 | PSG_020144 - Draft Guidance on Nitroglycerin | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:21:57 | 1 | 0 | 09000064b91df4d8 | |
| FDA-2007-D-0369-2432 | FDA | FDA-2007-D-0369 | PSG_018084 - Draft Guidance on Tolmetin Sodium | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:18:51 | 1 | 0 | 09000064b91df465 | |
| FDA-2007-D-0369-2457 | FDA | FDA-2007-D-0369 | PSG_021336 - Draft Guidance on Selegiline | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:26:39 | 1 | 0 | 09000064b91e011b | |
| FDA-2007-D-0369-2440 | FDA | FDA-2007-D-0369 | PSG_019982 - Draft Guidance on Bisoprolol Fumarate | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:21:21 | 1 | 0 | 09000064b91df4d4 | |
| FDA-2007-D-0369-2447 | FDA | FDA-2007-D-0369 | PSG_020375 - Draft Guidance on Estradiol | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:23:38 | 1 | 0 | 09000064b91df4f2 | |
| FDA-2007-D-0369-2438 | FDA | FDA-2007-D-0369 | PSG_019813 - Draft Guidance on Fentanyl | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:20:47 | 1 | 0 | 09000064b91df4d0 | |
| FDA-2007-D-0369-2459 | FDA | FDA-2007-D-0369 | PSG_021427 - Draft Guidance on Duloxetine Hydrochloride | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:27:37 | 1 | 0 | 09000064b91e011f | |
| FDA-2007-D-0369-2461 | FDA | FDA-2007-D-0369 | PSG_021514 - Draft Guidance on Methylphenidate | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:29:28 | 1 | 0 | 09000064b91e0123 | |
| FDA-2007-D-0369-2520 | FDA | FDA-2007-D-0369 | PSG_218466 - Draft Guidance on Alpelisib | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:50:12 | 1 | 0 | 09000064b91e01d3 | |
| FDA-2007-D-0369-2511 | FDA | FDA-2007-D-0369 | PSG_216352 - Draft Guidance on Paliperidone Palmitate | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:47:03 | 1 | 0 | 09000064b91e01b4 | |
| FDA-2007-D-0369-2512 | FDA | FDA-2007-D-0369 | PSG_216665 - Draft Guidance on Diazoxide Choline | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:47:20 | 1 | 0 | 09000064b91e01b6 | |
| FDA-2007-D-0369-2508 | FDA | FDA-2007-D-0369 | PSG_215431 - Draft Guidance on Meloxicam; Rizatriptan Benzoate | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:46:07 | 1 | 0 | 09000064b91e01ad | |
| FDA-2007-D-0369-2475 | FDA | FDA-2007-D-0369 | PSG_202211 - Draft Guidance on Oxybutynin | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:35:11 | 1 | 0 | 09000064b91e0140 | |
| FDA-2007-D-0369-2466 | FDA | FDA-2007-D-0369 | PSG_022029 - Draft Guidance on Menthol; Methyl Salicylate | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:31:54 | 1 | 0 | 09000064b91e012d | |
| FDA-2007-D-0369-2467 | FDA | FDA-2007-D-0369 | PSG_022083 - Draft Guidance on Rivastigmine | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:32:28 | 1 | 0 | 09000064b91e012f | |
| FDA-2007-D-0369-2464 | FDA | FDA-2007-D-0369 | PSG_021829 - Draft Guidance on Rotigotine | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:30:54 | 1 | 0 | 09000064b91e0129 | |
| FDA-2007-D-0369-2497 | FDA | FDA-2007-D-0369 | PSG_213224 - Draft Guidance on Octreotide acetate | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:42:17 | 1 | 0 | 09000064b91e018a | |
| FDA-2007-D-0369-2490 | FDA | FDA-2007-D-0369 | PSG_211843 - Draft Guidance on Tiopronin | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:39:55 | 1 | 0 | 09000064b91e0172 | |
| FDA-2007-D-0369-2481 | FDA | FDA-2007-D-0369 | PSG_207620 - Draft Guidance on Sacubitril; Valsartan | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:37:17 | 1 | 0 | 09000064b91e0156 | |
| FDA-2007-D-0369-2489 | FDA | FDA-2007-D-0369 | PSG_211733 - Draft Guidance on Acetaminophen; Ibuprofen | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:39:39 | 1 | 0 | 09000064b91e0170 | |
| FDA-2007-D-0369-2479 | FDA | FDA-2007-D-0369 | PSG_206089 - Draft Guidance on Testosterone Undecanoate | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:36:31 | 1 | 0 | 09000064b91e0152 | |
| FDA-2007-D-0369-2469 | FDA | FDA-2007-D-0369 | PSG_022264 - Draft Guidance on Paliperidone Palmitate | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:33:09 | 1 | 0 | 09000064b91e0133 | |
| FDA-2007-D-0369-2473 | FDA | FDA-2007-D-0369 | PSG_085635 - Draft Guidance on Testosterone Cypionate | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:34:27 | 1 | 0 | 09000064b91e013c | |
| FDA-2007-D-0369-2488 | FDA | FDA-2007-D-0369 | PSG_210868 - Draft Guidance on Lorlatinib | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:39:21 | 1 | 0 | 09000064b91e016e | |
| FDA-2007-D-0369-2486 | FDA | FDA-2007-D-0369 | PSG_209310 - Draft Guidance on Mometasone Furoate | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:38:46 | 1 | 0 | 09000064b91e016a | |
| FDA-2007-D-0369-2506 | FDA | FDA-2007-D-0369 | PSG_215401 - Draft Guidance on Dextroamphetamine | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:45:23 | 1 | 0 | 09000064b91e01a9 | |
| FDA-2007-D-0369-2522 | FDA | FDA-2007-D-0369 | PSG_218585 - Draft Guidance on Aceclidine Hydrochloride | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:51:02 | 1 | 0 | 09000064b91e01d7 | |
| FDA-2007-D-0369-2509 | FDA | FDA-2007-D-0369 | PSG_215602 - Draft Guidance on Baclofen | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:46:21 | 1 | 0 | 09000064b91e01af | |
| FDA-2007-D-0369-2516 | FDA | FDA-2007-D-0369 | PSG_217225 - Draft Guidance on Avacincaptad Pegol Sodium | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:48:56 | 1 | 0 | 09000064b91e01cb | |
| FDA-2007-D-0369-2507 | FDA | FDA-2007-D-0369 | PSG_215429 - Draft Guidance on Venlafaxine Besylate | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:45:49 | 1 | 0 | 09000064b91e01ab | |
| FDA-2007-D-0369-2443 | FDA | FDA-2007-D-0369 | PSG_020145 - Draft Guidance on Nitroglycerin | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:22:16 | 1 | 0 | 09000064b91df4da | |
| FDA-2007-D-0369-2460 | FDA | FDA-2007-D-0369 | PSG_021447 - Draft Guidance on Tizanidine Hydrochloride | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:27:59 | 1 | 0 | 09000064b91e0121 | |
| FDA-2007-D-0369-2446 | FDA | FDA-2007-D-0369 | PSG_020357 - Draft Guidance on Metformin Hydrochloride | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:23:14 | 1 | 0 | 09000064b91df4f0 | |
| FDA-2007-D-0369-2448 | FDA | FDA-2007-D-0369 | PSG_020489 - Draft Guidance on Testosterone | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:23:57 | 1 | 0 | 09000064b91df4f4 | |
| FDA-2007-D-0369-2454 | FDA | FDA-2007-D-0369 | PSG_021234 - Draft Guidance on Diclofenac Epolamine | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:25:35 | 1 | 0 | 09000064b91e010a | |
| FDA-2007-D-0369-2500 | FDA | FDA-2007-D-0369 | PSG_214410 - Draft Guidance on Baloxavir Marboxil | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:43:31 | 1 | 0 | 09000064b91e0190 | |
| FDA-2007-D-0369-2494 | FDA | FDA-2007-D-0369 | PSG_212516 - Draft Guidance on Duloxetine Hydrochloride | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:41:20 | 1 | 0 | 09000064b91e0184 | |
| FDA-2007-D-0369-2484 | FDA | FDA-2007-D-0369 | PSG_208143 - Draft Guidance on Barium Sulfate | Other | Guidance | 2026-02-27 | 2026 | 2 | 2026-02-27 | 2026-04-29 | 2026-02-27 19:38:13 | 1 | 0 | 09000064b91e015c |
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