documents
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896 rows where agency_id = "FDA", document_type = "Notice" and posted_year = 2023 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2021-N-0039-0002 | FDA | FDA-2021-N-0039 | Electronic Submissions; Update to the Specifications for Preparing and Submitting Postmarket Individual Case Safety Reports for Vaccines; Technical Specification | Notice | Notice of Availability | 2023-12-28T05:00:00Z | 2023 | 12 | 2023-12-28T05:00:00Z | 2024-11-12T06:21:06Z | 2023-28594 | 1 | 0 | 090000648636182b | |
| FDA-2023-D-4177-0021 | FDA | FDA-2023-D-4177 | Quality Considerations for Topical Ophthalmic Drug Products; Revised Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2023-12-28T05:00:00Z | 2023 | 12 | 2023-12-28T05:00:00Z | 2023-12-28T15:10:09Z | 2023-28595 | 0 | 0 | 090000648636165b | |
| FDA-2023-D-4299-0001 | FDA | FDA-2023-D-4299 | Potency Assurance for Cellular and Gene Therapy Products; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2023-12-28T05:00:00Z | 2023 | 12 | 2023-12-28T05:00:00Z | 2023-12-28T16:34:21Z | 2023-28596 | 0 | 0 | 090000648636182c | |
| FDA-2023-D-5408-0001 | FDA | FDA-2023-D-5408 | Reformulating Drug Products That Contain Carbomers Manufactured With Benzene; Guidance for Industry; Availability | Notice | Notice of Availability | 2023-12-28T05:00:00Z | 2023 | 12 | 2023-12-28T05:00:00Z | 2023-12-28T16:02:50Z | 2023-28675 | 0 | 0 | 090000648636165e | |
| FDA-2022-E-0931-0005 | FDA | FDA-2022-E-0931 | Determination of Regulatory Review Period for Purposes of Patent Extension; ZOKINVY | Notice | Determinations | 2023-12-27T05:00:00Z | 2023 | 12 | 2023-12-27T05:00:00Z | 2024-06-25T03:59:59Z | 2024-06-25T01:00:33Z | 2023-28511 | 0 | 0 | 090000648635c4ea |
| FDA-2023-F-5500-0001 | FDA | FDA-2023-F-5500 | Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use); Chromium Propionate; Correction. | Notice | Correction | 2023-12-27T05:00:00Z | 2023 | 12 | 2023-12-27T05:00:00Z | 2023-12-29T15:38:50Z | 2023-28512 | 0 | 0 | 090000648635c3a9 | |
| FDA-2023-F-2415-0004 | FDA | FDA-2023-F-2415 | Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use); Chromium Propionate; Correction. | Notice | Correction | 2023-12-27T05:00:00Z | 2023 | 12 | 2023-12-27T05:00:00Z | 2023-12-29T15:48:26Z | 2023-28512 | 0 | 0 | 090000648635d693 | |
| FDA-2022-E-0936-0005 | FDA | FDA-2022-E-0936 | Determination of Regulatory Review Period for Purposes of Patent Extension; ZOKINVY | Notice | Determinations | 2023-12-27T05:00:00Z | 2023 | 12 | 2023-12-27T05:00:00Z | 2024-06-25T03:59:59Z | 2023-12-27T15:24:10Z | 2023-28511 | 0 | 0 | 090000648635c012 |
| FDA-2022-E-2225-0005 | FDA | FDA-2022-E-2225 | Determination of Regulatory Review Period for Purposes of Patent Extension; SCEMBLIX | Notice | Determinations | 2023-12-27T05:00:00Z | 2023 | 12 | 2023-12-27T05:00:00Z | 2024-06-25T03:59:59Z | 2023-12-27T14:50:39Z | 2023-28519 | 0 | 0 | 090000648635c3e9 |
| FDA-2022-E-2035-0004 | FDA | FDA-2022-E-2035 | Determination of Regulatory Review Period for Purposes of Patent Extension; PONVORY | Notice | Determinations | 2023-12-27T05:00:00Z | 2023 | 12 | 2023-12-27T05:00:00Z | 2024-06-25T03:59:59Z | 2023-12-27T15:44:15Z | 2023-28509 | 0 | 0 | 090000648635c5cc |
| FDA-2022-E-0926-0005 | FDA | FDA-2022-E-0926 | Determination of Regulatory Review Period for Purposes of Patent Extension; CYTALUX | Notice | Determinations | 2023-12-27T05:00:00Z | 2023 | 12 | 2023-12-27T05:00:00Z | 2024-06-25T03:59:59Z | 2024-06-15T01:00:26Z | 2023-28507 | 0 | 0 | 090000648635c493 |
| FDA-2015-D-2818-0044 | FDA | FDA-2015-D-2818 | Rare Diseases: Considerations for the Development of Drugs and Biological Products; Guidance for Industry; Availability | Notice | Notice of Availability | 2023-12-26T05:00:00Z | 2023 | 12 | 2023-12-26T05:00:00Z | 2023-12-26T14:43:28Z | 2023-28310 | 0 | 0 | 0900006486359d43 | |
| FDA-2023-N-2986-0003 | FDA | FDA-2023-N-2986 | Agency Information Collection Activities; Proposals, Submissions, and Approvals | Notice | Notice of Approval | 2023-12-22T05:00:00Z | 2023 | 12 | 2024-01-08T13:21:53Z | 2023-28290 | 0 | 0 | 0900006486351613 | ||
| FDA-1997-D-0444-0037 | FDA | Guidance of Animal Drugs for Minor Uses & Minor Species FDA-1997-D-0444 | Special Considerations, Incentives, and Programs To Support the Approval of New Animal Drugs for Minor Uses and for Minor Species; Guidance for Industry; Availability | Notice | Notice of Availability | 2023-12-22T05:00:00Z | 2023 | 12 | 2023-12-22T15:18:01Z | 2023-28287 | 0 | 0 | 090000648635114c | ||
| FDA-2023-D-5259-0001 | FDA | FDA-2023-D-5259 | Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2023-12-22T05:00:00Z | 2023 | 12 | 2023-12-22T15:36:56Z | 2023-28210 | 0 | 0 | 0900006486351218 | ||
| FDA-2023-N-1157-0004 | FDA | FDA-2023-N-1157 | Agency Information Collection Activities; Proposals, Submissions, and Approvals | Notice | Notice of Approval | 2023-12-22T05:00:00Z | 2023 | 12 | 2024-01-04T22:17:54Z | 2023-28290 | 0 | 0 | 0900006486351117 | ||
| FDA-2013-N-1119-0018 | FDA | FDA-2013-N-1119 | Agency Information Collection Activities; Proposals, Submissions, and Approvals | Notice | Notice of Approval | 2023-12-22T05:00:00Z | 2023 | 12 | 2024-01-08T13:21:11Z | 2023-28290 | 0 | 0 | 0900006486351612 | ||
| FDA-2020-N-0908-0008 | FDA | FDA-2020-N-0908 | Agency Information Collection Activities; Proposals, Submissions, and Approvals | Notice | Notice of Approval | 2023-12-22T05:00:00Z | 2023 | 12 | 2024-01-08T13:14:23Z | 2023-28290 | 0 | 0 | 0900006486351564 | ||
| FDA-2022-D-0814-0008 | FDA | FDA-2022-D-0814 | Agency Information Collection Activities; Proposals, Submissions, and Approvals | Notice | Notice of Approval | 2023-12-22T05:00:00Z | 2023 | 12 | 2024-01-08T13:15:19Z | 2023-28290 | 0 | 0 | 0900006486351565 | ||
| FDA-2019-E-3287-0004 | FDA | FDA-2019-E-3287 | Determination of Regulatory Review Period for Purposes of Patent Extension; Copiktra | Notice | Determinations | 2023-12-22T05:00:00Z | 2023 | 12 | 2023-12-22T05:00:00Z | 2024-02-21T04:59:59Z | 2023-12-22T15:41:59Z | 2023-28244 | 0 | 0 | 090000648635121b |
| FDA-2021-D-0548-0036 | FDA | FDA-2021-D-0548 | Data Standards for Drug and Biological Product Submissions Containing Real-World Data; Guidance for Industry; Availability | Notice | Notice of Availability | 2023-12-22T05:00:00Z | 2023 | 12 | 2023-12-22T15:08:44Z | 2023-28291 | 0 | 0 | 0900006486351145 | ||
| FDA-2019-E-3017-0004 | FDA | FDA-2019-E-3017 | Determination of Regulatory Review Period for Purposes of Patent Extension; Emgality | Notice | Determinations | 2023-12-22T05:00:00Z | 2023 | 12 | 2023-12-22T05:00:00Z | 2024-02-21T04:59:59Z | 2023-12-22T14:20:59Z | 2023-28233 | 0 | 0 | 0900006486351116 |
| FDA-2023-N-1189-0004 | FDA | FDA-2023-N-1189 | Agency Information Collection Activities; Proposals, Submissions, and Approvals | Notice | Notice of Approval | 2023-12-22T05:00:00Z | 2023 | 12 | 2024-01-08T13:26:13Z | 2023-28290 | 0 | 0 | 09000064863516f6 | ||
| FDA-2023-N-1006-0004 | FDA | FDA-2023-N-1006 | Agency Information Collection Activities; Proposals, Submissions, and Approvals | Notice | Notice of Approval | 2023-12-22T05:00:00Z | 2023 | 12 | 2024-01-08T13:17:34Z | 2023-28290 | 0 | 0 | 090000648635160e | ||
| FDA-2021-D-1128-0065 | FDA | FDA-2021-D-1128 | Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Guidance for Industry, Investigators, and Other Stakeholders; Availability | Notice | Notice of Availability | 2023-12-22T05:00:00Z | 2023 | 12 | 2023-12-22T15:30:51Z | 2023-28262 | 0 | 0 | 0900006486351187 | ||
| FDA-2023-N-1661-0002 | FDA | FDA-2023-N-1661 | Agency Information Collection Activities; Proposals, Submissions, and Approvals | Notice | Notice of Approval | 2023-12-22T05:00:00Z | 2023 | 12 | 2024-01-08T13:20:18Z | 2023-28290 | 0 | 0 | 0900006486351611 | ||
| FDA-2023-N-1272-0005 | FDA | FDA-2023-N-1272 | Agency Information Collection Activities; Proposals, Submissions, and Approvals | Notice | Notice of Approval | 2023-12-22T05:00:00Z | 2023 | 12 | 2024-01-08T13:24:27Z | 2023-28290 | 0 | 0 | 0900006486351615 | ||
| FDA-2022-D-0745-0014 | FDA | FDA-2022-D-0745 | Agency Information Collection Activities; Proposals, Submissions, and Approvals | Notice | Notice of Approval | 2023-12-22T05:00:00Z | 2023 | 12 | 2024-01-08T13:16:39Z | 2023-28290 | 0 | 0 | 090000648635160d | ||
| FDA-2023-N-2286-0003 | FDA | FDA-2023-N-2286 | Agency Information Collection Activities; Proposals, Submissions, and Approvals | Notice | Notice of Approval | 2023-12-22T05:00:00Z | 2023 | 12 | 2024-01-08T13:19:03Z | 2023-28290 | 0 | 0 | 0900006486351610 | ||
| FDA-2023-N-2030-0005 | FDA | FDA-2023-N-2030 | Agency Information Collection Activities; Proposals, Submissions, and Approvals | Notice | Notice of Approval | 2023-12-22T05:00:00Z | 2023 | 12 | 2024-01-08T13:25:22Z | 2023-28290 | 0 | 0 | 0900006486351616 | ||
| FDA-2022-D-0109-0016 | FDA | FDA-2022-D-0109 | Agency Information Collection Activities; Proposals, Submissions, and Approvals | Notice | Notice of Approval | 2023-12-22T05:00:00Z | 2023 | 12 | 2024-01-08T13:13:11Z | 2023-28290 | 0 | 0 | 0900006486351562 | ||
| FDA-2021-D-1146-0042 | FDA | FDA-2021-D-1146 | Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry; Availability | Notice | Notice of Availability | 2023-12-22T05:00:00Z | 2023 | 12 | 2023-12-22T15:24:04Z | 2023-28289 | 0 | 0 | 090000648635117e | ||
| FDA-2009-N-0582-0129 | FDA | FDA-2009-N-0582 | Agency Information Collection Activities; Proposals, Submissions, and Approvals | Notice | Notice of Approval | 2023-12-22T05:00:00Z | 2023 | 12 | 2024-01-08T13:23:07Z | 2023-28290 | 0 | 0 | 0900006486351614 | ||
| FDA-2023-N-1053-0004 | FDA | FDA-2023-N-1053 | Agency Information Collection Activities; Proposals, Submissions, and Approvals | Notice | Notice of Approval | 2023-12-22T05:00:00Z | 2023 | 12 | 2024-01-08T13:18:22Z | 2023-28290 | 0 | 0 | 090000648635160f | ||
| FDA-2022-E-2013-0004 | FDA | FDA-2022-E-2013 | Determination of Regulatory Review Period for Purposes of Patent Extension; LYBALV | Notice | Determinations | 2023-12-21T05:00:00Z | 2023 | 12 | 2023-12-21T05:00:00Z | 2024-02-21T04:59:59Z | 2023-12-21T14:39:34Z | 2023-28094 | 0 | 0 | 090000648634dc9c |
| FDA-2022-E-2011-0004 | FDA | FDA-2022-E-2011 | Determination of Regulatory Review Period for Purposes of Patent Extension; LYBALV | Notice | Determinations | 2023-12-21T05:00:00Z | 2023 | 12 | 2023-12-21T05:00:00Z | 2024-02-21T04:59:59Z | 2023-12-21T15:32:46Z | 2023-28094 | 0 | 0 | 090000648634e3d5 |
| FDA-2022-E-2012-0004 | FDA | FDA-2022-E-2012 | Determination of Regulatory Review Period for Purposes of Patent Extension; LYBALV | Notice | Determinations | 2023-12-21T05:00:00Z | 2023 | 12 | 2023-12-21T05:00:00Z | 2024-02-21T04:59:59Z | 2023-12-21T15:40:37Z | 2023-28094 | 0 | 0 | 090000648634e3d6 |
| FDA-2022-E-2010-0004 | FDA | FDA-2022-E-2010 | Determination of Regulatory Review Period for Purposes of Patent Extension; LYBALV | Notice | Determinations | 2023-12-21T05:00:00Z | 2023 | 12 | 2023-12-21T05:00:00Z | 2024-02-21T04:59:59Z | 2023-12-21T15:29:45Z | 2023-28094 | 0 | 0 | 090000648634e3d4 |
| FDA-2020-D-1136-0084 | FDA | FDA-2020-D-1136 | Development of Monoclonal Antibody Products Targeting SARS–CoV–2 for Emergency Use Authorization; Guidance for Industry; Availability | Notice | Notice of Availability | 2023-12-21T05:00:00Z | 2023 | 12 | 2023-12-21T16:06:18Z | 2023-28092 | 0 | 0 | 090000648634e184 | ||
| FDA-2016-D-2565-0029 | FDA | FDA-2016-D-2565 | 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability | Notice | Notice of Availability | 2023-12-21T05:00:00Z | 2023 | 12 | 2023-12-21T17:23:07Z | 2023-28095 | 0 | 0 | 090000648634e286 | ||
| FDA-2022-E-2009-0004 | FDA | FDA-2022-E-2009 | Determination of Regulatory Review Period for Purposes of Patent Extension; LYBALV | Notice | Determinations | 2023-12-21T05:00:00Z | 2023 | 12 | 2023-12-21T05:00:00Z | 2024-02-21T04:59:59Z | 2023-12-21T15:26:24Z | 2023-28094 | 0 | 0 | 090000648634e3d3 |
| FDA-2023-N-4201-0001 | FDA | FDA-2023-N-4201 | Agency Information Collection Activities; Proposed Collection; Comment Request; Examination of Implied Claims in Direct-to-Consumer Prescription Drug Promotion | Notice | 60 Day Proposed Information Collection | 2023-12-21T05:00:00Z | 2023 | 12 | 2023-12-21T05:00:00Z | 2024-02-21T04:59:59Z | 2024-02-21T02:00:37Z | 2023-28093 | 0 | 0 | 090000648634dc45 |
| FDA-2023-N-5020-0001 | FDA | FDA-2023-N-5020 | Notice to Public of Website Location of the Office of the Chief Scientist Proposed Guidance Development List | Notice | General Notice | 2023-12-20T05:00:00Z | 2023 | 12 | 2023-12-20T05:00:00Z | 2025-01-24T02:01:16Z | 2023-27967 | 1 | 0 | 090000648634bbbc | |
| FDA-2023-D-1716-0053 | FDA | FDA-2023-D-1716 | Registration and Listing of Cosmetic Product Facilities and Products; Guidance for Industry; Availability | Notice | Notice of Availability | 2023-12-19T05:00:00Z | 2023 | 12 | 2023-12-19T05:00:00Z | 2023-12-19T15:33:24Z | 2023-27649 | 0 | 0 | 0900006486346b66 | |
| FDA-2023-P-4596-0004 | FDA | FDA-2023-P-4596 | Determination That MEPHYTON (Phytonadione) Tablets, 5 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Notice | Determinations | 2023-12-19T05:00:00Z | 2023 | 12 | 2023-12-19T05:00:00Z | 2023-12-19T16:46:30Z | 2023-27858 | 0 | 0 | 0900006486346c55 | |
| FDA-2023-N-5431-0001 | FDA | FDA-2023-N-5431 | Hospira, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications | Notice | Withdrawal | 2023-12-19T05:00:00Z | 2023 | 12 | 2023-12-19T05:00:00Z | 2023-12-19T16:19:50Z | 2023-27853 | 0 | 0 | 0900006486346be7 | |
| FDA-2023-D-4395-0001 | FDA | FDA-2023-D-4395 | Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff; Availability | Notice | Notice of Availability | 2023-12-19T05:00:00Z | 2023 | 12 | 2023-12-19T05:00:00Z | 2023-12-19T16:31:03Z | 2023-27852 | 0 | 0 | 0900006486346c20 | |
| FDA-2023-N-2080-0002 | FDA | FDA-2023-N-2080 | Jeremy Walenty: Final Debarment Order | Notice | Statutory Debarment | 2023-12-19T05:00:00Z | 2023 | 12 | 2023-12-19T05:00:00Z | 2023-12-20T04:59:59Z | 2024-11-12T06:22:14Z | 2023-27855 | 1 | 0 | 0900006486346be3 |
| FDA-2009-N-0026-0005 | FDA | FDA-2009-N-0026 | Apothecon, et al.; Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated New Drug Applications; Correction | Notice | Correction | 2023-12-19T05:00:00Z | 2023 | 12 | 2023-12-19T05:00:00Z | 2023-12-19T15:58:07Z | 2023-27859 | 0 | 0 | 0900006486346ba5 | |
| FDA-2023-N-2058-0002 | FDA | FDA-2023-N-2058 | James Funaro: Final Debarment Order | Notice | Statutory Debarment | 2023-12-19T05:00:00Z | 2023 | 12 | 2023-12-19T05:00:00Z | 2023-12-20T04:59:59Z | 2024-11-12T06:22:13Z | 2023-27854 | 1 | 0 | 0900006486346ba7 |
| FDA-2023-N-5344-0001 | FDA | FDA-2023-N-5344 | Pharmacyclics LLC.; Withdrawal of Approval of Indications for Mantle Cell Lymphoma and Marginal Zone Lymphoma for IMBRUVICA (ibrutinib) Capsules and Tablets | Notice | Withdrawal | 2023-12-18T05:00:00Z | 2023 | 12 | 2023-12-18T05:00:00Z | 2023-12-18T14:30:13Z | 2023-27662 | 0 | 0 | 09000064863439f9 | |
| FDA-2023-D-3740-0001 | FDA | FDA-2023-D-3740 | Priority Zoonotic Animal Drug Designation and Review Process; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2023-12-18T05:00:00Z | 2023 | 12 | 2023-12-18T05:00:00Z | 2023-12-18T14:17:53Z | 2023-27655 | 0 | 0 | 0900006486343903 | |
| FDA-2023-N-5323-0001 | FDA | FDA-2023-N-5323 | Hoffmann-La Roche, Inc., et al.; Withdrawal of Approval of Two New Drug Applications | Notice | Withdrawal | 2023-12-18T05:00:00Z | 2023 | 12 | 2023-12-18T05:00:00Z | 2023-12-18T14:31:47Z | 2023-27661 | 0 | 0 | 0900006486343a3b | |
| FDA-2023-N-0795-0007 | FDA | FDA-2023-N-0795 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; A Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising | Notice | 30 Day Proposed Information Collection | 2023-12-18T05:00:00Z | 2023 | 12 | 2023-12-18T05:00:00Z | 2024-01-18T04:59:59Z | 2024-01-17T02:00:34Z | 2023-27652 | 0 | 0 | 090000648634394b |
| FDA-2023-N-3369-0002 | FDA | FDA-2023-N-3369 | Adam Michael Nagy: Final Debarment Order | Notice | Statutory Debarment | 2023-12-15T05:00:00Z | 2023 | 12 | 2023-12-15T05:00:00Z | 2023-12-16T04:59:59Z | 2024-11-12T06:24:30Z | 2023-27557 | 1 | 0 | 090000648633c5ab |
| FDA-2023-D-4974-0001 | FDA | FDA-2023-D-4974 | Advanced Manufacturing Technologies Designation Program; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request | Notice | Notice of Availability | 2023-12-13T05:00:00Z | 2023 | 12 | 2023-12-13T05:00:00Z | 2024-03-14T03:59:59Z | 2024-03-14T01:00:49Z | 2023-27309 | 0 | 0 | 09000064863313ba |
| FDA-2023-N-1506-0012 | FDA | FDA-2023-N-1506 | Methodological Challenges Related to Patient Experience Data; Summary of Received Comments | Notice | General Notice | 2023-12-13T05:00:00Z | 2023 | 12 | 2023-12-13T05:00:00Z | 2023-12-13T16:28:58Z | 2023-27312 | 0 | 0 | 0900006486331450 | |
| FDA-2023-N-0008-0014 | FDA | FDA-2023-N-0008 | Request for Nominations of Individuals and Industry Organizations for the Genetic Metabolic Diseases Advisory Committee | Notice | Request for Nominations | 2023-12-13T05:00:00Z | 2023 | 12 | 2023-12-13T05:00:00Z | 2023-12-13T15:38:07Z | 2023-27303 | 0 | 0 | 090000648633149a | |
| FDA-2022-N-0008-0015 | FDA | FDA-2022-N-0008 | Request for Nominations for Individuals and Consumer Organizations for Advisory Committees | Notice | Request for Nominations | 2023-12-13T05:00:00Z | 2023 | 12 | 2023-12-13T05:00:00Z | 2023-12-13T16:56:07Z | 2023-27308 | 0 | 0 | 090000648633144b | |
| FDA-2023-N-5022-0001 | FDA | FDA-2023-N-5022 | Data Standards Support and Requirement Begins for the Clinical Data Interchange Standards Consortium Version 2.0 of the Study Data Tabulation Model Version 3.4 of the Study Data Tabulation Model Implementation Guide and Version 1.0 of the Standard for Exchange of Nonclinical Data Implementation Guide- Genetox; Requirement Ends for the Clinical Data Interchange Standards Version 3.2 of the Study | Notice | General Notice | 2023-12-13T05:00:00Z | 2023 | 12 | 2023-12-13T05:00:00Z | 2024-11-12T06:24:34Z | 2023-27310 | 1 | 0 | 09000064863319e1 | |
| FDA-2023-N-4917-0001 | FDA | FDA-2023-N-4917 | Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Establishment | Notice | Advisory Committee | 2023-12-13T05:00:00Z | 2023 | 12 | 2023-12-13T05:00:00Z | 2024-02-13T04:59:59Z | 2024-02-13T02:00:24Z | 2023-27304 | 0 | 0 | 09000064863313f1 |
| FDA-1999-D-4088-0001 | FDA | Industry on BA/BE Studies Orally Administered Drug Products FDA-1999-D-4088 | Draft Guidance for Industry on BA and BE Studies for Orally Administered Drug Products-General Considerations; Availability | Notice | Notice of Data Availability | 2023-12-13T05:00:00Z | 2023 | 12 | 2023-12-13T05:00:00Z | 1999-11-03T04:59:59Z | 2023-12-13T15:12:37Z | 99-23009 | 0 | 0 | 09000064804f5ef6 |
| FDA-2023-N-0008-0013 | FDA | FDA-2023-N-0008 | Request for Nominations of Individuals and Consumer Organizations for the Genetic Metabolic Diseases Advisory Committee | Notice | Request for Nominations | 2023-12-13T05:00:00Z | 2023 | 12 | 2023-12-13T05:00:00Z | 2023-12-13T15:34:25Z | 2023-27302 | 0 | 0 | 090000648633198f | |
| FDA-2023-N-0008-0015 | FDA | FDA-2023-N-0008 | Request for Nominations for Voting Members for the Genetic Metabolic Diseases Advisory Committee | Notice | Request for Nominations | 2023-12-13T05:00:00Z | 2023 | 12 | 2023-12-13T05:00:00Z | 2023-12-13T16:51:45Z | 2023-27301 | 0 | 0 | 09000064863313f5 | |
| FDA-2022-E-2095-0004 | FDA | FDA-2022-E-2095 | Determination of Regulatory Review Period for Purposes of Patent Extension; WELIREG | Notice | Determinations | 2023-12-11T05:00:00Z | 2023 | 12 | 2023-12-11T05:00:00Z | 2024-02-10T04:59:59Z | 2023-12-11T14:17:00Z | 2023-27044 | 0 | 0 | 0900006486320d30 |
| FDA-2022-E-2096-0004 | FDA | FDA-2022-E-2096 | Determination of Regulatory Review Period for Purposes of Patent Extension; WELIREG | Notice | Determinations | 2023-12-11T05:00:00Z | 2023 | 12 | 2023-12-11T05:00:00Z | 2024-02-10T04:59:59Z | 2023-12-11T14:15:12Z | 2023-27044 | 0 | 0 | 0900006486320e8b |
| FDA-2022-E-0248-0004 | FDA | FDA-2022-E-0248 | Determination of Regulatory Review Period for Purposes of Patent Extension; ZYNLONTA | Notice | Determinations | 2023-12-08T05:00:00Z | 2023 | 12 | 2023-12-08T05:00:00Z | 2024-02-07T04:59:59Z | 2023-12-08T14:00:21Z | 2023-26982 | 0 | 0 | 0900006486316537 |
| FDA-2022-E-2103-0005 | FDA | FDA-2022-E-2103 | Determination of Regulatory Review Period for Purposes of Patent Extension; EXKIVITY | Notice | Determinations | 2023-12-08T05:00:00Z | 2023 | 12 | 2023-12-08T05:00:00Z | 2024-02-07T04:59:59Z | 2023-12-08T13:46:28Z | 2023-27004 | 0 | 0 | 090000648631602a |
| FDA-2019-E-5256-0004 | FDA | FDA-2019-E-5256 | Determination of Regulatory Review Period for Purposes of Patent Extension; SEYSARA | Notice | Determinations | 2023-12-08T05:00:00Z | 2023 | 12 | 2023-12-08T05:00:00Z | 2024-02-07T04:59:59Z | 2023-12-08T14:19:46Z | 2023-27003 | 0 | 0 | 09000064863165a2 |
| FDA-2022-E-2195-0004 | FDA | FDA-2022-E-2195 | Determination of Regulatory Review Period for Purposes of Patent Extension; Tivdak | Notice | Determinations | 2023-12-08T05:00:00Z | 2023 | 12 | 2023-12-08T05:00:00Z | 2024-02-07T04:59:59Z | 2023-12-08T15:33:28Z | 2023-26992 | 0 | 0 | 090000648631751c |
| FDA-2023-N-2851-0002 | FDA | FDA-2023-N-2851 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Time and Extent Applications for Nonprescription Drug Products | Notice | 30 Day Proposed Information Collection | 2023-12-08T05:00:00Z | 2023 | 12 | 2023-12-08T05:00:00Z | 2024-01-09T04:59:59Z | 2023-12-08T15:05:26Z | 2023-26985 | 0 | 0 | 09000064863166bc |
| FDA-2019-E-5267-0004 | FDA | FDA-2019-E-5267 | Determination of Regulatory Review Period for Purposes of Patent Extension; Nuzyra Tablets (New Drug Application 209816) | Notice | Determinations | 2023-12-08T05:00:00Z | 2023 | 12 | 2023-12-08T05:00:00Z | 2024-02-07T04:59:59Z | 2023-12-08T14:12:23Z | 2023-26989 | 0 | 0 | 090000648631653b |
| FDA-2022-E-2014-0004 | FDA | FDA-2022-E-2014 | Determination of Regulatory Review Period for Purposes of Patent Extension; Fotivda | Notice | Determinations | 2023-12-08T05:00:00Z | 2023 | 12 | 2023-12-08T05:00:00Z | 2024-02-07T04:59:59Z | 2023-12-08T14:27:55Z | 2023-26997 | 0 | 0 | 09000064863165ec |
| FDA-2022-E-2196-0004 | FDA | FDA-2022-E-2196 | Determination of Regulatory Review Period for Purposes of Patent Extension; Tivdak | Notice | Determinations | 2023-12-08T05:00:00Z | 2023 | 12 | 2023-12-08T05:00:00Z | 2024-02-07T04:59:59Z | 2023-12-08T15:35:41Z | 2023-26992 | 0 | 0 | 090000648631751d |
| FDA-2022-E-2194-0004 | FDA | FDA-2022-E-2194 | Determination of Regulatory Review Period for Purposes of Patent Extension; Tivdak | Notice | Determinations | 2023-12-08T05:00:00Z | 2023 | 12 | 2023-12-08T05:00:00Z | 2024-02-07T04:59:59Z | 2023-12-08T15:27:22Z | 2023-26992 | 0 | 0 | 09000064863166f6 |
| FDA-2022-E-2016-0004 | FDA | FDA-2022-E-2016 | Determination of Regulatory Review Period for Purposes of Patent Extension; Fotivda | Notice | Determinations | 2023-12-08T05:00:00Z | 2023 | 12 | 2023-12-08T05:00:00Z | 2024-02-07T04:59:59Z | 2023-12-08T14:30:04Z | 2023-26997 | 0 | 0 | 0900006486316031 |
| FDA-2023-N-4849-0001 | FDA | FDA-2023-N-4849 | Agency Information Collection Activities; Proposed Collection; Comment Request; Food Allergen Labeling and Reporting | Notice | 60 Day Proposed Information Collection | 2023-12-08T05:00:00Z | 2023 | 12 | 2023-12-08T05:00:00Z | 2024-02-07T04:59:59Z | 2023-12-21T02:04:32Z | 2023-27018 | 0 | 0 | 09000064863166bf |
| FDA-2023-N-3859-0002 | FDA | FDA-2023-N-3859 | Dr. Reddy’s Laboratories, Inc.; Withdrawal of Approval of 11 Abbreviated New Drug Applications; Correction | Notice | Correction | 2023-12-08T05:00:00Z | 2023 | 12 | 2023-12-08T05:00:00Z | 2023-12-08T14:40:44Z | 2023-26994 | 0 | 0 | 09000064863165ed | |
| FDA-2023-N-4973-0001 | FDA | FDA-2023-N-4973 | Bayer HealthCare Pharmaceuticals Inc., et al.; Withdrawal of Approval of CIPRO (Ciprofloxacin Hydrochloride) Oral Tablet, Equivalent to 100 Milligrams Base, and Five Generic Ciprofloxacin Hydrochloride, Oral | Notice | Withdrawal | 2023-12-08T05:00:00Z | 2023 | 12 | 2023-12-08T05:00:00Z | 2023-12-08T15:17:20Z | 2023-27015 | 0 | 0 | 09000064863166f5 | |
| FDA-2022-E-2102-0005 | FDA | FDA-2022-E-2102 | Determination of Regulatory Review Period for Purposes of Patent Extension; EXKIVITY | Notice | Determinations | 2023-12-08T05:00:00Z | 2023 | 12 | 2023-12-08T05:00:00Z | 2024-02-07T04:59:59Z | 2023-12-08T13:44:24Z | 2023-27004 | 0 | 0 | 09000064863164a4 |
| FDA-2021-E-0791-0005 | FDA | FDA-2021-E-0791 | Determination of Regulatory Review Period for Purposes of Patent Extension; VILTEPSO | Notice | Determinations | 2023-12-08T05:00:00Z | 2023 | 12 | 2023-12-08T05:00:00Z | 2024-02-07T04:59:59Z | 2023-12-08T14:24:16Z | 2023-27013 | 0 | 0 | 09000064863165a3 |
| FDA-2019-E-3218-0004 | FDA | FDA-2019-E-3218 | Determination of Regulatory Review Period for Purposes of Patent Extension; VIZIMPRO | Notice | Determinations | 2023-12-08T05:00:00Z | 2023 | 12 | 2023-12-08T05:00:00Z | 2024-02-07T04:59:59Z | 2023-12-08T13:51:58Z | 2023-27012 | 0 | 0 | 09000064863164a6 |
| FDA-2022-E-0249-0005 | FDA | FDA-2022-E-0249 | Determination of Regulatory Review Period for Purposes of Patent Extension; Pemazyre | Notice | Determinations | 2023-12-08T05:00:00Z | 2023 | 12 | 2023-12-08T05:00:00Z | 2024-02-07T04:59:59Z | 2023-12-08T14:50:24Z | 2023-26996 | 0 | 0 | 0900006486317518 |
| FDA-2021-E-1091-0005 | FDA | FDA-2021-E-1091 | Determination of Regulatory Review Period for Purposes of Patent Extension; Pemazyre | Notice | Determinations | 2023-12-08T05:00:00Z | 2023 | 12 | 2023-12-08T05:00:00Z | 2024-02-07T04:59:59Z | 2023-12-08T14:47:16Z | 2023-26996 | 0 | 0 | 0900006486316628 |
| FDA-2022-E-2185-0004 | FDA | FDA-2022-E-2185 | Determination of Regulatory Review Period for Purposes of Patent Extension; Nextstellis | Notice | Determinations | 2023-12-08T05:00:00Z | 2023 | 12 | 2023-12-08T05:00:00Z | 2024-02-07T04:59:59Z | 2023-12-08T14:56:17Z | 2023-26988 | 0 | 0 | 090000648631666f |
| FDA-2015-D-3517-0021 | FDA | FDA-2015-D-3517 | Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2023-12-07T05:00:00Z | 2023 | 12 | 2023-12-07T05:00:00Z | 2023-12-07T14:38:58Z | 2023-26886 | 0 | 0 | 09000064863099ff | |
| FDA-2018-D-3462-0021 | FDA | FDA-2018-D-3462 | Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Guidance for Industry; Availability | Notice | Notice of Availability | 2023-12-07T05:00:00Z | 2023 | 12 | 2023-12-07T05:00:00Z | 2023-12-07T14:50:23Z | 2023-26846 | 0 | 0 | 090000648630b20b | |
| FDA-2015-D-3539-0019 | FDA | FDA-2015-D-3539 | Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2023-12-07T05:00:00Z | 2023 | 12 | 2023-12-07T05:00:00Z | 2023-12-07T14:46:02Z | 2023-26845 | 0 | 0 | 090000648630b16d | |
| FDA-2022-E-2136-0004 | FDA | FDA-2022-E-2136 | Determination of Regulatory Review Period for Purposes of Patent Extension; Truseltiq | Notice | Determinations | 2023-12-07T05:00:00Z | 2023 | 12 | 2023-12-07T05:00:00Z | 2024-02-06T04:59:59Z | 2023-12-07T15:08:31Z | 2023-26885 | 0 | 0 | 090000648630ab6a |
| FDA-2020-N-0026-0024 | FDA | FDA-2020-N-0026 | Issuance of Priority Review Voucher; Rare Pediatric Disease Product | Notice | Announcement | 2023-12-05T05:00:00Z | 2023 | 12 | 2023-12-05T05:00:00Z | 2023-12-05T17:53:57Z | 2023-26652 | 0 | 0 | 09000064862f4366 | |
| FDA-2017-N-5569-0010 | FDA | FDA-2017-N-5569 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Device Tracking | Notice | 30 Day Proposed Information Collection | 2023-12-05T05:00:00Z | 2023 | 12 | 2023-12-05T05:00:00Z | 2024-01-05T04:59:59Z | 2024-01-04T02:00:34Z | 2023-26653 | 0 | 0 | 09000064862f4412 |
| FDA-2023-N-0009-0003 | FDA | FDA-2023-N-0009 | Statement of Organization, Functions, and Delegations of Authority | Notice | General Notice | 2023-12-05T05:00:00Z | 2023 | 12 | 2023-12-05T05:00:00Z | 2023-12-05T19:02:37Z | 2023-26512 | 0 | 0 | 09000064862f42da | |
| FDA-2023-N-2564-0004 | FDA | FDA-2023-N-2564 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations | Notice | 30 Day Proposed Information Collection | 2023-12-04T05:00:00Z | 2023 | 12 | 2023-12-04T05:00:00Z | 2024-01-04T04:59:59Z | 2023-12-04T17:38:55Z | 2023-26564 | 0 | 0 | 09000064862e3610 |
| FDA-2023-N-1929-0002 | FDA | FDA-2023-N-1929 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs | Notice | 30 Day Proposed Information Collection | 2023-12-04T05:00:00Z | 2023 | 12 | 2023-12-04T05:00:00Z | 2024-01-04T04:59:59Z | 2023-12-04T17:10:48Z | 2023-26544 | 0 | 0 | 09000064862e35cb |
| FDA-2014-N-1051-0941 | FDA | FDA-2014-N-1051 | Modified Risk Tobacco Product Application: Renewal Applications for General Snus Smokeless Tobacco Products Submitted by Swedish Match U.S.A., Inc. | Notice | Request for Comments | 2023-12-01T05:00:00Z | 2023 | 12 | 2023-12-01T05:00:00Z | 2024-08-15T03:59:59Z | 2024-08-15T01:01:12Z | 2023-26498 | 0 | 0 | 09000064862d1bb7 |
| FDA-2023-N-3007-0002 | FDA | FDA-2023-N-3007 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated Fees | Notice | 30 Day Proposed Information Collection | 2023-12-01T05:00:00Z | 2023 | 12 | 2023-12-01T05:00:00Z | 2024-01-03T04:59:59Z | 2023-12-11T02:00:18Z | 2023-26445 | 0 | 0 | 09000064862d1c05 |
| FDA-2019-E-5262-0004 | FDA | FDA-2019-E-5262 | Determination of Regulatory Review Period for Purposes of Patent Extension; Nuzyra Injection (New Drug Application 209817) | Notice | Determinations | 2023-11-30T05:00:00Z | 2023 | 11 | 2023-11-30T05:00:00Z | 2024-05-29T03:59:59Z | 2023-11-30T18:17:29Z | 2023-26363 | 0 | 0 | 09000064862c3351 |
| FDA-2022-E-0680-0004 | FDA | FDA-2022-E-0680 | Determination of Regulatory Review Period for Purposes of Patent Extension; Amondys 45 | Notice | Determinations | 2023-11-30T05:00:00Z | 2023 | 11 | 2023-11-30T05:00:00Z | 2024-05-29T03:59:59Z | 2023-11-30T18:10:37Z | 2023-26299 | 0 | 0 | 09000064862c32e0 |
| FDA-2023-N-2459-0003 | FDA | FDA-2023-N-2459 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Product Jurisdiction and Combination Products | Notice | 30 Day Proposed Information Collection | 2023-11-30T05:00:00Z | 2023 | 11 | 2023-11-30T05:00:00Z | 2024-01-03T04:59:59Z | 2023-11-30T18:25:59Z | 2023-26262 | 0 | 0 | 09000064862c3240 |
| FDA-2022-E-2028-0004 | FDA | FDA-2022-E-2028 | Determination of Regulatory Review Period for Purposes of Patent Extension; Qelbree | Notice | Determinations | 2023-11-30T05:00:00Z | 2023 | 11 | 2023-11-30T05:00:00Z | 2024-05-29T03:59:59Z | 2023-11-30T17:07:32Z | 2023-26301 | 0 | 0 | 09000064862c32de |
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CREATE TABLE documents (
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);