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withdrawn,object_id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FDA-2023-D-4177-0021,FDA,FDA-2023-D-4177,Quality Considerations for Topical Ophthalmic Drug Products; Revised Draft Guidance for Industry; Availability,Notice,Notice of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FDA-2023-D-4299-0001,FDA,FDA-2023-D-4299,Potency Assurance for Cellular and Gene Therapy Products; Draft Guidance for Industry; Availability,Notice,Notice of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,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,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