documents
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804 rows where agency_id = "FDA", document_type = "Notice" and posted_year = 2024 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2024-N-3271-0002 | FDA | FDA-2024-N-3271 | Flamingo Pharmaceuticals Ltd.; Withdrawal of Approval of Two Abbreviated New Drug Applications | Notice | Withdrawal | 2024-12-31T05:00:00Z | 2024 | 12 | 2024-12-31T05:00:00Z | 2024-12-31T14:36:36Z | 2024-31360 | 0 | 0 | 0900006486896c82 | |
| FDA-2024-N-2980-0006 | FDA | FDA-2024-N-2980 | Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products; Reopening of the Comment Period | Notice | Extension of Comment Period | 2024-12-31T05:00:00Z | 2024 | 12 | 2024-12-31T05:00:00Z | 2024-12-31T14:48:35Z | 2024-31365 | 0 | 0 | 0900006486896ad4 | |
| FDA-2024-N-5830-0001 | FDA | FDA-2024-N-5830 | Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory Committee; Renewal | Notice | Notice of Renewal | 2024-12-31T05:00:00Z | 2024 | 12 | 2024-12-31T05:00:00Z | 2024-12-31T14:00:03Z | 2024-31363 | 0 | 0 | 0900006486896cc5 | |
| FDA-2016-E-4588-0006 | FDA | FDA-2016-E-4588 | Determination of Regulatory Review Period for Purposes of Patent Extension; XTAMPZA ER | Notice | Determinations | 2024-12-30T05:00:00Z | 2024 | 12 | 2024-12-30T05:00:00Z | 2025-03-01T04:59:59Z | 2025-02-24T02:00:23Z | 2024-31023 | 0 | 0 | 0900006486894b77 |
| FDA-2023-N-4597-0003 | FDA | FDA-2023-N-4597 | Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Shortages Data Collection | Notice | Notice of Approval | 2024-12-30T05:00:00Z | 2024 | 12 | 2024-12-30T05:00:00Z | 2024-12-30T16:46:09Z | 2024-31025 | 0 | 0 | 0900006486894ecc | |
| FDA-2024-D-5580-0001 | FDA | FDA-2024-D-5580 | M15 General Principles for Model- Informed Drug Development; International Council for Harmonisation; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2024-12-30T05:00:00Z | 2024 | 12 | 2024-12-30T05:00:00Z | 2024-12-30T16:48:34Z | 2024-31027 | 0 | 0 | 0900006486894ec6 | |
| FDA-2024-N-3248-0002 | FDA | FDA-2024-N-3248 | Fosun Pharma USA Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction | Notice | Correction | 2024-12-30T05:00:00Z | 2024 | 12 | 2024-12-30T05:00:00Z | 2024-12-30T16:31:46Z | 2024-31307 | 0 | 0 | 0900006486894fe2 | |
| FDA-2024-N-0008-0018 | FDA | FDA-2024-N-0008 | Request for Nominations for Individuals and Consumer Organizations for Advisory Committees | Notice | Request for Nominations | 2024-12-30T05:00:00Z | 2024 | 12 | 2024-12-30T05:00:00Z | 2024-12-30T15:53:25Z | 2024-31270 | 0 | 0 | 09000064868951c3 | |
| FDA-2024-N-5702-0001 | FDA | FDA-2024-N-5702 | Transfer of Regulatory Responsibility From the Center for Devices and Radiological Health to the Center for Biologics Evaluation and Research; Medical Maggots and Medicinal Leeches | Notice | Announcement | 2024-12-30T05:00:00Z | 2024 | 12 | 2024-12-30T05:00:00Z | 2024-12-30T15:46:44Z | 2024-31266 | 0 | 0 | 09000064868951c6 | |
| FDA-2024-N-0846-0003 | FDA | FDA-2024-N-0846 | Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; National Agriculture and Food Defense Strategy Survey | Notice | Notice of Approval | 2024-12-30T05:00:00Z | 2024 | 12 | 2024-12-30T05:00:00Z | 2024-12-30T15:00:00Z | 2024-31298 | 0 | 0 | 090000648689526c | |
| FDA-2024-E-0302-0008 | FDA | FDA-2024-E-0302 | Determination of Regulatory Review Period for Purposes of Patent Extension; VEOZAH | Notice | Determinations | 2024-12-30T05:00:00Z | 2024 | 12 | 2024-12-30T05:00:00Z | 2025-03-01T04:59:59Z | 2024-12-30T17:41:51Z | 2024-31269 | 0 | 0 | 0900006486894bff |
| FDA-2024-N-2149-0002 | FDA | FDA-2024-N-2149 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; De Novo Classification Process (Evaluation of Automatic Class III Designation) | Notice | 30 Day Proposed Information Collection | 2024-12-30T05:00:00Z | 2024 | 12 | 2024-12-30T05:00:00Z | 2025-01-30T04:59:59Z | 2024-12-30T16:29:16Z | 2024-31014 | 0 | 0 | 090000648689502a |
| FDA-2024-E-0299-0008 | FDA | FDA-2024-E-0299 | Determination of Regulatory Review Period for Purposes of Patent Extension; VEOZAH | Notice | Determinations | 2024-12-30T05:00:00Z | 2024 | 12 | 2024-12-30T05:00:00Z | 2025-03-01T04:59:59Z | 2024-12-30T17:37:48Z | 2024-31269 | 0 | 0 | 0900006486894779 |
| FDA-2024-E-0301-0008 | FDA | FDA-2024-E-0301 | Determination of Regulatory Review Period for Purposes of Patent Extension; VEOZAH | Notice | Determinations | 2024-12-30T05:00:00Z | 2024 | 12 | 2024-12-30T05:00:00Z | 2025-03-01T04:59:59Z | 2024-12-30T17:40:00Z | 2024-31269 | 0 | 0 | 0900006486894bfc |
| FDA-2022-D-1562-0007 | FDA | FDA-2022-D-1562 | E11A Pediatric Extrapolation; International Council for Harmonisation; Guidance for Industry; Availability | Notice | Notice of Availability | 2024-12-30T05:00:00Z | 2024 | 12 | 2024-12-30T05:00:00Z | 2024-12-30T16:34:31Z | 2024-31026 | 0 | 0 | 0900006486894f00 | |
| FDA-2024-N-5603-0001 | FDA | FDA-2024-N-5603 | Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug and Veterinary Master Files | Notice | 60 Day Proposed Information Collection | 2024-12-30T05:00:00Z | 2024 | 12 | 2024-12-30T05:00:00Z | 2025-03-01T04:59:59Z | 2024-12-30T17:13:43Z | 2024-31308 | 0 | 0 | 0900006486894dc0 |
| FDA-2016-E-4590-0007 | FDA | FDA-2016-E-4590 | Determination of Regulatory Review Period for Purposes of Patent Extension; XTAMPZA ER | Notice | Determinations | 2024-12-30T05:00:00Z | 2024 | 12 | 2024-12-30T05:00:00Z | 2025-03-01T04:59:59Z | 2024-12-30T17:07:31Z | 2024-31023 | 0 | 0 | 0900006486894b76 |
| FDA-2024-D-5601-0001 | FDA | FDA-2024-D-5601 | E6(R3) Good Clinical Practice: Annex 2; International Council for Harmonisation; Draft Guidance | Notice | Notice of Availability | 2024-12-30T05:00:00Z | 2024 | 12 | 2024-12-30T05:00:00Z | 2024-12-30T16:08:36Z | 2024-31275 | 0 | 0 | 0900006486895165 | |
| FDA-2024-E-0441-0006 | FDA | FDA-2024-E-0441 | Determination of Regulatory Review Period for Purposes of Patent Extension; ROCTAVIAN | Notice | Determinations | 2024-12-30T05:00:00Z | 2024 | 12 | 2024-12-30T05:00:00Z | 2025-03-01T04:59:59Z | 2024-12-30T17:34:49Z | 2024-31276 | 0 | 0 | 0900006486894bfb |
| FDA-2024-E-0440-0006 | FDA | FDA-2024-E-0440 | Determination of Regulatory Review Period for Purposes of Patent Extension; ROCTAVIAN | Notice | Determinations | 2024-12-30T05:00:00Z | 2024 | 12 | 2024-12-30T05:00:00Z | 2025-03-01T04:59:59Z | 2024-12-30T17:32:54Z | 2024-31276 | 0 | 0 | 09000064868947c5 |
| FDA-2024-N-5720-0001 | FDA | FDA-2024-N-5720 | General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of Public Docket; Request for Comments—Dermal Fillers | Notice | Request for Comments | 2024-12-30T05:00:00Z | 2024 | 12 | 2024-12-30T05:00:00Z | 2025-03-21T03:59:59Z | 2025-01-03T02:01:03Z | 2024-31260 | 0 | 0 | 09000064868952f8 |
| FDA-2024-D-4490-0001 | FDA | FDA-2024-D-4490 | Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing Document; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2024-12-30T05:00:00Z | 2024 | 12 | 2024-12-30T05:00:00Z | 2024-12-30T14:15:28Z | 2024-31305 | 0 | 0 | 09000064868952fc | |
| FDA-2023-E-3269-0005 | FDA | FDA-2023-E-3269 | Determination of Regulatory Review Period for Purposes of Patent Extension; NEXOBRID | Notice | Determinations | 2024-12-30T05:00:00Z | 2024 | 12 | 2024-12-30T05:00:00Z | 2025-03-01T04:59:59Z | 2024-12-30T17:20:18Z | 2024-31022 | 0 | 0 | 0900006486894d0e |
| FDA-2023-D-5016-0001 | FDA | FDA-2023-D-5016 | Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2024-12-30T05:00:00Z | 2024 | 12 | 2024-12-30T05:00:00Z | 2024-12-30T17:22:51Z | 2024-31261 | 0 | 0 | 09000064868947c7 | |
| FDA-2024-E-0223-0006 | FDA | FDA-2024-E-0223 | Determination of Regulatory Review Period for Purposes of Patent Extension; OMISIRGE | Notice | Determinations | 2024-12-30T05:00:00Z | 2024 | 12 | 2024-12-30T05:00:00Z | 2025-03-01T04:59:59Z | 2024-12-30T17:17:19Z | 2024-31262 | 0 | 0 | 0900006486894d5f |
| FDA-2016-E-4589-0006 | FDA | FDA-2016-E-4589 | Determination of Regulatory Review Period for Purposes of Patent Extension; XTAMPZA ER | Notice | Determinations | 2024-12-30T05:00:00Z | 2024 | 12 | 2024-12-30T05:00:00Z | 2025-03-01T04:59:59Z | 2024-12-30T17:05:09Z | 2024-31023 | 0 | 0 | 0900006486894e08 |
| FDA-2024-N-0008-0019 | FDA | FDA-2024-N-0008 | Request for Nominations of Individuals and Industry Organizations for the Patient Engagement Advisory Committee | Notice | Request for Nominations | 2024-12-30T05:00:00Z | 2024 | 12 | 2024-12-30T05:00:00Z | 2024-12-30T16:23:57Z | 2024-31272 | 0 | 0 | 09000064868950cb | |
| FDA-2024-N-5717-0001 | FDA | FDA-2024-N-5717 | Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments— Supplemental New Drug Application 218276 S–004 for FABHALTA (iptacopan) Oral Capsules in the Treatment of Adults With C3G | Notice | Request for Comments | 2024-12-30T05:00:00Z | 2024 | 12 | 2024-12-30T05:00:00Z | 2025-02-22T04:59:59Z | 2025-02-22T02:00:45Z | 2024-31309 | 0 | 0 | 09000064868952b7 |
| FDA-2024-N-5381-0001 | FDA | FDA-2024-N-5381 | Modifications to Labeling of Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependence | Notice | Announcement | 2024-12-27T05:00:00Z | 2024 | 12 | 2024-12-27T05:00:00Z | 2024-12-27T16:47:11Z | 2024-30776 | 0 | 0 | 090000648689153c | |
| FDA-2024-N-0009-0009 | FDA | FDA-2024-N-0009 | Statement of Organization, Functions, and Delegations of Authority | Notice | General Notice | 2024-12-26T05:00:00Z | 2024 | 12 | 2024-12-26T05:00:00Z | 2024-12-26T14:18:34Z | 2024-30334 | 0 | 0 | 090000648688c609 | |
| FDA-2024-N-5353-0001 | FDA | FDA-2024-N-5353 | Privacy Act of 1974; System of Records | Notice | System of Records | 2024-12-26T05:00:00Z | 2024 | 12 | 2024-12-26T05:00:00Z | 2025-01-28T04:59:59Z | 2024-12-26T14:43:22Z | 2024-30782 | 0 | 0 | 090000648688c592 |
| FDA-2024-N-4776-0006 | FDA | FDA-2024-N-4776 | Export Lists for Human Food: Request for Information; Extension of Comment Period | Notice | Extension of Comment Period | 2024-12-26T05:00:00Z | 2024 | 12 | 2024-12-26T05:00:00Z | 2024-12-26T16:08:47Z | 2024-30784 | 0 | 0 | 090000648688bf77 | |
| FDA-2024-N-0009-0008 | FDA | FDA-2024-N-0009 | Statement of Organization, Functions, and Delegations of Authority | Notice | General Notice | 2024-12-23T05:00:00Z | 2024 | 12 | 2024-12-23T05:00:00Z | 2024-12-23T19:55:59Z | 2024-30333 | 0 | 0 | 09000064868864d4 | |
| FDA-2024-N-3902-0002 | FDA | FDA-2024-N-3902 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution and Related Collections of Information | Notice | 30 Day Proposed Information Collection | 2024-12-20T05:00:00Z | 2024 | 12 | 2024-12-20T05:00:00Z | 2025-01-22T04:59:59Z | 2024-12-20T14:17:07Z | 2024-30355 | 0 | 0 | 09000064868815dc |
| FDA-2024-N-1055-0003 | FDA | FDA-2024-N-1055 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request Data To Support Social and Behavioral Research as Used by the Food and Drug Administration | Notice | 30 Day Proposed Information Collection | 2024-12-19T05:00:00Z | 2024 | 12 | 2024-12-19T05:00:00Z | 2025-01-22T04:59:59Z | 2024-12-19T14:01:47Z | 2024-30224 | 0 | 0 | 090000648687e61e |
| FDA-2024-N-5234-0001 | FDA | FDA-2024-N-5234 | Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling: Notification Procedures for Statements on Dietary Supplements | Notice | 60 Day Proposed Information Collection | 2024-12-19T05:00:00Z | 2024 | 12 | 2024-12-19T05:00:00Z | 2025-02-19T04:59:59Z | 2024-12-19T14:06:06Z | 2024-30231 | 0 | 0 | 090000648687e1fc |
| FDA-2024-N-5581-0001 | FDA | FDA-2024-N-5581 | Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additives Intended for Use in Animal Food, Food Additive Petitions, Investigational Food Additive Files Exemptions, and Declaration on Animal Food Labels | Notice | 60 Day Proposed Information Collection | 2024-12-19T05:00:00Z | 2024 | 12 | 2024-12-19T05:00:00Z | 2025-02-19T04:59:59Z | 2025-02-13T02:00:40Z | 2024-30227 | 0 | 0 | 090000648687e731 |
| FDA-2024-N-5338-0001 | FDA | FDA-2024-N-5338 | Agency Information Collection Activities; Proposed Collection; Comment Request; Interstate Shellfish Dealer’s Certificate and Participation in the National Shellfish Sanitation Program | Notice | 60 Day Proposed Information Collection | 2024-12-19T05:00:00Z | 2024 | 12 | 2024-12-19T05:00:00Z | 2025-02-19T04:59:59Z | 2025-02-14T02:00:11Z | 2024-30228 | 0 | 0 | 090000648687e0d5 |
| FDA-2024-N-3379-0002 | FDA | FDA-2024-N-3379 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Laboratory Accreditation for Analyses of Foods | Notice | 30 Day Proposed Information Collection | 2024-12-19T05:00:00Z | 2024 | 12 | 2024-12-19T05:00:00Z | 2025-01-22T04:59:59Z | 2024-12-19T14:11:32Z | 2024-30230 | 0 | 0 | 090000648687e1fb |
| FDA-2022-E-0682-0006 | FDA | FDA-2022-E-0682 | Determination of Regulatory Review Period for Purposes of Patent Extension; BYLVAY | Notice | Determinations | 2024-12-18T05:00:00Z | 2024 | 12 | 2024-12-18T05:00:00Z | 2025-02-19T04:59:59Z | 2025-02-20T02:00:26Z | 2024-29966 | 0 | 0 | 090000648687b924 |
| FDA-2024-E-0198-0007 | FDA | FDA-2024-E-0198 | Determination of Regulatory Review Period for Purposes of Patent Extension; SOHONOS | Notice | Determinations | 2024-12-18T05:00:00Z | 2024 | 12 | 2024-12-18T05:00:00Z | 2025-02-19T04:59:59Z | 2024-12-20T18:22:56Z | 2024-29964 | 0 | 0 | 090000648687b925 |
| FDA-2024-E-0196-0007 | FDA | FDA-2024-E-0196 | Determination of Regulatory Review Period for Purposes of Patent Extension; SOHONOS | Notice | Determinations | 2024-12-18T05:00:00Z | 2024 | 12 | 2024-12-18T05:00:00Z | 2025-02-19T04:59:59Z | 2024-12-20T18:21:56Z | 2024-29964 | 0 | 0 | 090000648687b927 |
| FDA-2024-E-0197-0007 | FDA | FDA-2024-E-0197 | Determination of Regulatory Review Period for Purposes of Patent Extension; SOHONOS | Notice | Determinations | 2024-12-18T05:00:00Z | 2024 | 12 | 2024-12-18T05:00:00Z | 2025-02-19T04:59:59Z | 2024-12-20T18:22:24Z | 2024-29964 | 0 | 0 | 090000648687b926 |
| FDA-2023-N-0119-0008 | FDA | FDA-2023-N-0119 | Fiscal Year 2025 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments | Notice | Request for Comments | 2024-12-18T05:00:00Z | 2024 | 12 | 2024-12-18T05:00:00Z | 2025-07-08T03:59:59Z | 2025-07-05T09:00:19Z | 2024-29962 | 0 | 0 | 090000648687ad2f |
| FDA-2024-N-2844-0003 | FDA | FDA-2024-N-2844 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices | Notice | 30 Day Proposed Information Collection | 2024-12-18T05:00:00Z | 2024 | 12 | 2024-12-18T05:00:00Z | 2025-01-18T04:59:59Z | 2024-12-20T18:27:22Z | 2024-29955 | 0 | 0 | 090000648687ad2b |
| FDA-2022-E-0681-0006 | FDA | FDA-2022-E-0681 | Determination of Regulatory Review Period for Purposes of Patent Extension; BYLVAY | Notice | Determinations | 2024-12-18T05:00:00Z | 2024 | 12 | 2024-12-18T05:00:00Z | 2025-02-19T04:59:59Z | 2024-12-20T18:16:19Z | 2024-29966 | 0 | 0 | 090000648687b50b |
| FDA-2024-E-0195-0007 | FDA | FDA-2024-E-0195 | Determination of Regulatory Review Period for Purposes of Patent Extension; SOHONOS | Notice | Determinations | 2024-12-18T05:00:00Z | 2024 | 12 | 2024-12-18T05:00:00Z | 2025-02-19T04:59:59Z | 2024-12-20T18:21:17Z | 2024-29964 | 0 | 0 | 090000648687af27 |
| FDA-2022-E-0683-0006 | FDA | FDA-2022-E-0683 | Determination of Regulatory Review Period for Purposes of Patent Extension; BYLVAY | Notice | Determinations | 2024-12-18T05:00:00Z | 2024 | 12 | 2024-12-18T05:00:00Z | 2025-02-19T04:59:59Z | 2024-12-20T18:17:08Z | 2024-29966 | 0 | 0 | 090000648687b21e |
| FDA-2023-D-4974-0031 | FDA | FDA-2023-D-4974 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Advanced Manufacturing Technologies Designation Program | Notice | 30 Day Proposed Information Collection | 2024-12-18T05:00:00Z | 2024 | 12 | 2024-12-18T05:00:00Z | 2025-01-18T04:59:59Z | 2024-12-18T22:12:06Z | 2024-29954 | 0 | 0 | 090000648687b567 |
| FDA-2024-N-5375-0001 | FDA | FDA-2024-N-5375 | Revocation of Authorization of Emergency Use of B. Braun Medical’s Perfusor Space Syringe Infusion Pump System, Infusomat Space Volumetric Infusion Pump System, and Outlook ES; Availability | Notice | Announcement | 2024-12-12T05:00:00Z | 2024 | 12 | 2024-12-13T16:07:35Z | 2024-29247 | 0 | 0 | 090000648686642c | ||
| FDA-2024-N-0008-0017 | FDA | FDA-2024-N-0008 | Advisory Committee; Science Board to the Food and Drug Administration;Renewal | Notice | Renewals | 2024-12-12T05:00:00Z | 2024 | 12 | 2024-12-12T14:25:11Z | 2024-29231 | 0 | 0 | 09000064868663e5 | ||
| FDA-2023-D-1716-0058 | FDA | FDA-2023-D-1716 | Registration and Listing of Cosmetic Product Facilities and Products; Guidance for Industry; Availability | Notice | Notice of Availability | 2024-12-12T05:00:00Z | 2024 | 12 | 2024-12-12T14:37:21Z | 2024-29237 | 0 | 0 | 0900006486865cfe | ||
| FDA-2001-N-0431-0001 | FDA | Medical Devices Classification/GHTF Study Group 1 FDA-2001-N-0431 | Medical Devices; Global Harmonization Task Force; Study Group 1; Working Draft "Medical Devices Classification;" Availability | Notice | Notice of Data Availability | 2024-12-10T05:00:00Z | 2024 | 12 | 2024-12-10T05:00:00Z | 2001-07-02T03:59:59Z | 2024-12-12T02:01:01Z | 01-12226 | 0 | 0 | 090000648685fcc5 |
| FDA-2018-D-0481-0011 | FDA | FDA-2018-D-0481 | Standardized Format for Electronic Submission of Marketing Application Content for the Planning of Bioresearch Monitoring Inspections for Center for Drug Evaluation and Research Submissions; Guidance for Industry; Availability | Notice | Notice of Availability | 2024-12-09T05:00:00Z | 2024 | 12 | 2024-12-09T14:34:19Z | 2024-28807 | 0 | 0 | 0900006486856197 | ||
| FDA-2024-N-5331-0001 | FDA | FDA-2024-N-5331 | Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments— Extended-Release/Long-Acting Opioid Analgesic Postmarketing Requirement | Notice | Request for Comments | 2024-12-09T05:00:00Z | 2024 | 12 | 2024-12-09T05:00:00Z | 2025-02-05T04:59:59Z | 2025-04-21T15:10:18Z | 2024-28811 | 0 | 0 | 0900006486856209 |
| FDA-2024-D-2033-0001 | FDA | FDA-2024-D-2033 | Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2024-12-06T05:00:00Z | 2024 | 12 | 2024-12-06T05:00:00Z | 2025-06-08T00:55:36Z | 2024-28392 | 0 | 0 | 090000648684b49a | |
| FDA-2024-N-5354-0001 | FDA | FDA-2024-N-5354 | Determination That Bentyl Preservative Free (Dicyclomine Hydrochloride) Injection, 10 Milligrams/Milliliters, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Notice | Determinations | 2024-12-05T05:00:00Z | 2024 | 12 | 2024-12-05T05:00:00Z | 2024-12-05T13:50:43Z | 2024-28433 | 0 | 0 | 0900006486849ae1 | |
| FDA-2024-N-0604-0010 | FDA | FDA-2024-N-0604 | Yong Sheng Jiao; Denial of Hearing; Final Debarment Order | Notice | Statutory Debarment | 2024-12-05T05:00:00Z | 2024 | 12 | 2024-12-05T05:00:00Z | 2024-12-05T13:56:24Z | 2024-28452 | 1 | 0 | 0900006486849adc | |
| FDA-2022-D-2628-0035 | FDA | FDA-2022-D-2628 | Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions; Guidance for Industry and Food and Drug Administration Staff; Availability | Notice | Notice of Availability | 2024-12-04T05:00:00Z | 2024 | 12 | 2024-12-04T14:43:53Z | 2024-28361 | 0 | 0 | 0900006486848770 | ||
| FDA-2024-D-1334-0001 | FDA | FDA-2024-D-1334 | Notifying the Food and Drug Administration of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request | Notice | Notice of Availability | 2024-12-04T05:00:00Z | 2024 | 12 | 2024-12-04T14:30:12Z | 2024-28230 | 0 | 0 | 09000064868487b9 | ||
| FDA-1993-D-0285-0012 | FDA | Guide for Target Animal/Human Food Safety, Anti-Infective Bovine FDA-1993-D-0285 | Evaluating Target Animal Safety and Effectiveness of Antibacterial New Animal Drugs for Bovine Mastitis; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2024-12-04T05:00:00Z | 2024 | 12 | 2024-12-04T14:13:25Z | 2024-28362 | 0 | 0 | 0900006486848834 | ||
| FDA-2023-N-5653-0035 | FDA | FDA-2023-N-5653 | Food and Drug Administration Report and Plan on Best Practices for Guidance; Availability | Notice | Notice of Availability | 2024-12-03T05:00:00Z | 2024 | 12 | 2024-12-03T05:00:00Z | 2024-12-03T14:32:56Z | 2024-28228 | 0 | 0 | 0900006486846e99 | |
| FDA-2024-N-4821-0001 | FDA | FDA-2024-N-4821 | Food and Drug Administration’s Best Practices for Food and Drug Administration Communication With Interested Parties: Draft Report for Public Comment; Availability | Notice | Notice of Availability | 2024-12-03T05:00:00Z | 2024 | 12 | 2024-12-03T05:00:00Z | 2024-12-03T14:28:39Z | 2024-28229 | 0 | 0 | 0900006486846ee3 | |
| FDA-2024-N-1636-0002 | FDA | FDA-2024-N-1636 | Issuance of Priority Review Voucher; Rare Pediatric Disease Product; KEBILIDI (eladocagene exuparvovectneq) | Notice | Announcement | 2024-12-02T05:00:00Z | 2024 | 12 | 2024-12-02T05:00:00Z | 2024-12-02T15:11:50Z | 2024-28206 | 0 | 0 | 0900006486843d8e | |
| FDA-2024-N-4085-0026 | FDA | FDA-2024-N-4085 | Advancing Smoking Cessation: Food and Drug Administration and National Institutes of Health Priorities; Public Meeting; Request for Comments; Reopening of Public Comment Period | Notice | Extension of Comment Period | 2024-12-02T05:00:00Z | 2024 | 12 | 2024-12-02T13:43:03Z | 2024-28205 | 0 | 0 | 0900006486843e07 | ||
| FDA-2024-N-5253-0001 | FDA | FDA-2024-N-5253 | Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments— Biologics License Application 761393 for Condoliase Injection | Notice | Request for Comments | 2024-12-02T05:00:00Z | 2024 | 12 | 2024-12-02T05:00:00Z | 2025-01-10T04:59:59Z | 2025-01-10T02:00:46Z | 2024-28210 | 0 | 0 | 09000064868434ce |
| FDA-2024-N-4731-0001 | FDA | FDA-2024-N-4731 | Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices | Notice | 60 Day Proposed Information Collection | 2024-11-29T05:00:00Z | 2024 | 11 | 2024-11-29T05:00:00Z | 2025-01-29T04:59:59Z | 2024-11-29T15:29:20Z | 2024-28044 | 0 | 0 | 090000648683e886 |
| FDA-2024-N-4754-0001 | FDA | FDA-2024-N-4754 | Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators | Notice | 60 Day Proposed Information Collection | 2024-11-29T05:00:00Z | 2024 | 11 | 2024-11-29T05:00:00Z | 2025-01-29T04:59:59Z | 2025-01-29T02:00:56Z | 2024-28034 | 0 | 0 | 090000648683f0a1 |
| FDA-2022-D-0084-0021 | FDA | FDA-2022-D-0084 | Use of Circulating Tumor Deoxyribonucleic Acid for Curative- Intent Solid Tumor Drug Development; Guidance for Industry; Availability | Notice | Notice of Availability | 2024-11-29T05:00:00Z | 2024 | 11 | 2024-11-29T05:00:00Z | 2024-11-29T15:07:39Z | 2024-28033 | 0 | 0 | 090000648683f00a | |
| FDA-2024-N-4687-0001 | FDA | FDA-2024-N-4687 | Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application | Notice | 60 Day Proposed Information Collection | 2024-11-29T05:00:00Z | 2024 | 11 | 2024-11-29T05:00:00Z | 2025-01-29T04:59:59Z | 2024-11-29T15:20:43Z | 2024-28036 | 0 | 0 | 090000648683efa4 |
| FDA-2024-D-4643-0001 | FDA | FDA-2024-D-4643 | Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2024-11-27T05:00:00Z | 2024 | 11 | 2024-11-27T05:00:00Z | 2024-11-27T14:51:02Z | 2024-27804 | 0 | 0 | 090000648683b280 | |
| FDA-2018-N-3236-0003 | FDA | FDA-2018-N-3236 | Advisory Committee; Oncologic Drugs Advisory Committee; Renewal | Notice | Notice of Renewal | 2024-11-27T05:00:00Z | 2024 | 11 | 2024-11-27T05:00:00Z | 2024-11-27T15:34:59Z | 2024-27797 | 0 | 0 | 090000648683b12a | |
| FDA-2024-D-4540-0001 | FDA | FDA-2024-D-4540 | Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2024-11-27T05:00:00Z | 2024 | 11 | 2024-11-27T05:00:00Z | 2024-11-27T15:40:10Z | 2024-27796 | 0 | 0 | 090000648683a82d | |
| FDA-2024-N-2888-0010 | FDA | FDA-2024-N-2888 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substantial Equivalence Reports for Tobacco Products | Notice | 30 Day Proposed Information Collection | 2024-11-26T05:00:00Z | 2024 | 11 | 2024-11-26T05:00:00Z | 2024-12-27T04:59:59Z | 2024-11-26T15:28:47Z | 2024-27654 | 0 | 0 | 0900006486837e77 |
| FDA-2024-D-2274-0001 | FDA | FDA-2024-D-2274 | Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices; Guidance for Industry and Food and Drug Administration Staff; Availability | Notice | Notice of Availability | 2024-11-26T05:00:00Z | 2024 | 11 | 2024-11-26T13:54:19Z | 2024-27661 | 0 | 0 | 0900006486837dfa | ||
| FDA-2024-N-2889-0009 | FDA | FDA-2024-N-2889 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Tobacco Product Applications and Recordkeeping Requirements | Notice | 30 Day Proposed Information Collection | 2024-11-26T05:00:00Z | 2024 | 11 | 2024-11-26T05:00:00Z | 2024-12-27T04:59:59Z | 2024-11-26T15:39:03Z | 2024-27655 | 0 | 0 | 0900006486837e30 |
| FDA-2018-N-0180-0014 | FDA | FDA-2018-N-0180 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications | Notice | 30 Day Proposed Information Collection | 2024-11-25T05:00:00Z | 2024 | 11 | 2024-11-25T05:00:00Z | 2024-12-27T04:59:59Z | 2024-12-11T02:00:58Z | 2024-27483 | 0 | 0 | 0900006486833a0c |
| FDA-2023-D-0488-0004 | FDA | FDA-2023-D-0488 | Orthopedic Non-Spinal Bone Plates, Screws, and Washers—Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability | Notice | Notice of Availability | 2024-11-22T05:00:00Z | 2024 | 11 | 2024-11-22T05:00:00Z | 2024-11-22T14:35:50Z | 2024-27114 | 0 | 0 | 090000648682e4f0 | |
| FDA-2024-N-3609-5234 | FDA | FDA-2024-N-3609 | Development of an Enhanced Systematic Process for the Food and Drug Administration’s Post-Market Assessment of Chemicals in Food; Public Meeting; Request for Comments; Extension of Comment Period | Notice | Extension of Comment Period | 2024-11-21T05:00:00Z | 2024 | 11 | 2024-11-22T14:23:51Z | 2024-27289 | 0 | 0 | 090000648682b632 | ||
| FDA-2016-D-2565-0035 | FDA | FDA-2016-D-2565 | 510(k) Third Party Review Program and Third Party Emergency Use Authorization Review; Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability | Notice | Notice of Availability | 2024-11-21T05:00:00Z | 2024 | 11 | 2024-11-21T14:14:28Z | 2024-27085 | 0 | 0 | 090000648682c244 | ||
| FDA-2024-P-2515-0004 | FDA | FDA-2024-P-2515 | Determination That FORTESTA (Testosterone) Gel, 10 Milligrams/0.5 Gram Actuation, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Notice | Determinations | 2024-11-20T05:00:00Z | 2024 | 11 | 2024-11-20T05:00:00Z | 2024-11-20T14:44:01Z | 2024-27103 | 0 | 0 | 090000648682a069 | |
| FDA-2024-N-0009-0007 | FDA | FDA-2024-N-0009 | Statement of Organization, Functions, and Delegations of Authority | Notice | General Notice | 2024-11-20T05:00:00Z | 2024 | 11 | 2024-11-20T05:00:00Z | 2024-11-20T14:39:58Z | 2024-27011 | 0 | 0 | 090000648682a0ad | |
| FDA-2024-P-3699-0003 | FDA | FDA-2024-P-3699 | Determination That IC-GREEN (Indocyanine Green), 25 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Notice | Determinations | 2024-11-20T05:00:00Z | 2024 | 11 | 2024-11-20T05:00:00Z | 2024-11-20T14:59:40Z | 2024-27090 | 0 | 0 | 0900006486829fdf | |
| FDA-2007-D-0369-2006 | FDA | FDA-2007-D-0369 | Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability | Notice | Notice of Availability | 2024-11-20T05:00:00Z | 2024 | 11 | 2024-11-20T05:00:00Z | 2024-11-21T19:50:01Z | 2024-27048 | 0 | 0 | 0900006486829e19 | |
| FDA-2024-N-4604-0001 | FDA | FDA-2024-N-4604 | Per- and Polyfluoroalkyl Substances in Seafood; Request for Information | Notice | Requests for Information (RFI) | 2024-11-20T05:00:00Z | 2024 | 11 | 2024-11-20T05:00:00Z | 2025-02-19T04:59:59Z | 2025-02-20T02:00:35Z | 2024-27070 | 0 | 0 | 090000648682a61c |
| FDA-2024-P-4163-0006 | FDA | FDA-2024-P-4163 | Determination That NOXAFIL (Posaconazole) Delayed-Release Tablets, 100 Grams Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness; Correction | Notice | Correction | 2024-11-20T05:00:00Z | 2024 | 11 | 2024-11-20T05:00:00Z | 2024-11-20T14:53:38Z | 2024-27082 | 0 | 0 | 0900006486829fe2 | |
| FDA-2024-N-3110-0002 | FDA | FDA-2024-N-3110 | Miguel Angel Montalvo Villa: Final Debarment Order | Notice | General Notice | 2024-11-20T05:00:00Z | 2024 | 11 | 2024-11-20T05:00:00Z | 2024-11-21T19:48:38Z | 2024-27093 | 1 | 0 | 090000648682a0b2 | |
| FDA-2022-N-0150-0013 | FDA | FDA-2022-N-0150 | Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID–19; Availability | Notice | Announcement | 2024-11-20T05:00:00Z | 2024 | 11 | 2024-11-20T05:00:00Z | 2024-11-20T14:49:41Z | 2024-27094 | 0 | 0 | 0900006486829fe4 | |
| FDA-2024-P-3482-0003 | FDA | FDA-2024-P-3482 | Determination That JESDUVROQ (daprodustat) Tablets, 1 Milligram, 2 Milligrams, 4 Milligrams, 6 Milligrams, and 8 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Notice | Determinations | 2024-11-19T05:00:00Z | 2024 | 11 | 2024-11-19T05:00:00Z | 2024-11-19T15:23:17Z | 2024-26915 | 0 | 0 | 090000648682768f | |
| FDA-2024-N-3111-0002 | FDA | FDA-2024-N-3111 | Ivette Maria Portela Martinez: Final Debarment Order | Notice | Statutory Debarment | 2024-11-19T05:00:00Z | 2024 | 11 | 2024-11-19T05:00:00Z | 2024-11-19T13:28:57Z | 2024-26912 | 1 | 0 | 0900006486827777 | |
| FDA-2023-E-2611-0006 | FDA | FDA-2023-E-2611 | Determination of Regulatory Review Period for Purposes of Patent Extension; AGILI–C | Notice | Determinations | 2024-11-19T05:00:00Z | 2024 | 11 | 2024-11-19T05:00:00Z | 2025-01-22T04:59:59Z | 2024-11-19T13:37:18Z | 2024-26910 | 0 | 0 | 0900006486827d2d |
| FDA-2024-N-4860-0001 | FDA | FDA-2024-N-4860 | Pfizer, Inc., et al.; Withdrawal of Approval of 26 New Drug Applications | Notice | Withdrawal | 2024-11-19T05:00:00Z | 2024 | 11 | 2024-11-19T05:00:00Z | 2024-11-19T15:18:07Z | 2024-26913 | 0 | 0 | 0900006486827693 | |
| FDA-2020-P-1991-0005 | FDA | FDA-2020-P-1991 | Determination That HYDROCORTONE (Hydrocortisone Sodium Phosphate) Injection, Equivalent to 50 Milligrams Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Notice | Determinations | 2024-11-19T05:00:00Z | 2024 | 11 | 2024-11-19T05:00:00Z | 2024-11-19T13:22:51Z | 2024-26916 | 0 | 0 | 0900006486827825 | |
| FDA-2024-D-4311-0001 | FDA | FDA-2024-D-4311 | Frequently Asked Questions—Developing Potential Cellular and Gene Therapy Products; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2024-11-19T05:00:00Z | 2024 | 11 | 2024-11-19T05:00:00Z | 2024-11-19T14:45:46Z | 2024-26918 | 0 | 0 | 09000064868276db | |
| FDA-2023-E-2610-0006 | FDA | FDA-2023-E-2610 | Determination of Regulatory Review Period for Purposes of Patent Extension; AGILI–C | Notice | Determinations | 2024-11-19T05:00:00Z | 2024 | 11 | 2024-11-19T05:00:00Z | 2025-01-22T04:59:59Z | 2024-11-19T13:34:39Z | 2024-26910 | 0 | 0 | 090000648682771d |
| FDA-2024-N-1178-0002 | FDA | FDA-2024-N-1178 | Kevin Sheng Hsiang Fang: Final Debarment Order | Notice | Statutory Debarment | 2024-11-19T05:00:00Z | 2024 | 11 | 2024-11-19T05:00:00Z | 2024-11-19T13:18:29Z | 2024-26917 | 1 | 0 | 0900006486827858 | |
| FDA-2021-P-0940-0004 | FDA | FDA-2021-P-0940 | Determination That HYDROCORTONE (Hydrocortisone Sodium Phosphate) Injection, Equivalent to 50 Milligrams Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Notice | Determinations | 2024-11-19T05:00:00Z | 2024 | 11 | 2024-11-19T05:00:00Z | 2024-11-19T13:25:25Z | 2024-26916 | 0 | 0 | 0900006486827d2c | |
| FDA-2024-N-4467-0001 | FDA | FDA-2024-N-4467 | Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug User Fee Program | Notice | 60 Day Proposed Information Collection | 2024-11-18T05:00:00Z | 2024 | 11 | 2024-11-18T05:00:00Z | 2025-01-18T04:59:59Z | 2024-12-05T02:00:48Z | 2024-26801 | 0 | 0 | 090000648681f48c |
| FDA-2024-D-4624-0001 | FDA | FDA-2024-D-4624 | Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2024-11-15T05:00:00Z | 2024 | 11 | 2024-11-15T05:00:00Z | 2024-11-15T14:15:24Z | 2024-26682 | 0 | 0 | 0900006486817487 | |
| FDA-2024-N-4815-0001 | FDA | FDA-2024-N-4815 | Patient-Focused Drug Development: Workshop To Discuss Methodologic and Other Challenges Related to Patient Experience Data; Public Workshop; Request for Comments | Notice | Request for Comments | 2024-11-14T05:00:00Z | 2024 | 11 | 2024-11-14T05:00:00Z | 2025-02-12T04:59:59Z | 2025-02-12T02:00:33Z | 2024-26399 | 0 | 0 | 0900006486815282 |
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id TEXT PRIMARY KEY,
agency_id TEXT,
docket_id TEXT REFERENCES dockets(id),
title TEXT,
document_type TEXT,
subtype TEXT,
posted_date TEXT,
posted_year INTEGER,
posted_month INTEGER,
comment_start_date TEXT,
comment_end_date TEXT,
last_modified TEXT,
fr_doc_num TEXT,
open_for_comment INTEGER,
withdrawn INTEGER,
object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);