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withdrawn,object_id FDA-2015-D-4750-0528,FDA,FDA-2015-D-4750,Stakeholder Meeting Summary APC Final2,Other,Summary (SUM),2023-03-27T04:00:00Z,2023,3,2023-03-27T04:00:00Z,,2023-03-27T18:33:47Z,,0,0,090000648586cdbe FDA-2015-D-4750-0527,FDA,FDA-2015-D-4750,APC and OFA - FDA Meeting Summary Memorandum - 11-15-21,Other,Memorandum,2023-03-23T04:00:00Z,2023,3,2023-03-23T04:00:00Z,,2023-03-23T15:34:38Z,,0,0,0900006485833052 FDA-2015-D-4750-0438,FDA,FDA-2015-D-4750,The ‘‘Deemed To Be a License’’ Provision of the Biologics Price Competition and Innovation Act: Questions and Answers; Guidance for Industry; Availability,Notice,Notice of Availability,2020-03-05T05:00:00Z,2020,3,2020-03-05T05:00:00Z,,2020-03-05T13:45:14Z,2020-04537,0,0,09000064843ed60b FDA-2015-D-4750-0439,FDA,FDA-2015-D-4750,"The ""Deemed To Be a License"" Provision of the BPCI Act; Questions and Answers; Guidance for Industry",Other,Guidance,2020-03-05T05:00:00Z,2020,3,2020-03-05T05:00:00Z,,2026-03-02T10:00:13Z,,1,0,09000064843eda81 FDA-2015-D-4750-0026,FDA,FDA-2015-D-4750,Request for Extension from Foley & Lardner LLP,Other,Request for Extension,2019-02-08T05:00:00Z,2019,2,2019-02-08T05:00:00Z,,2019-02-08T21:39:11Z,,0,0,0900006483a582de FDA-2015-D-4750-0027,FDA,FDA-2015-D-4750,"Request for Extension from Foley & Lardner, LLP",Other,Request for Extension,2019-02-08T05:00:00Z,2019,2,2019-02-08T05:00:00Z,,2019-02-08T21:56:15Z,,0,0,0900006483a5830a FDA-2015-D-4750-0021,FDA,FDA-2015-D-4750,The ‘‘Deemed to be a License’’ Provision of the BPCI Act: Questions and Answers; Draft Guidance for Industry; Availability; Request for Comments on Preliminary List of Affected Applications,Notice,Notice of Availability,2018-12-12T05:00:00Z,2018,12,2018-12-12T05:00:00Z,2019-02-12T04:59:59Z,2024-11-12T22:51:55Z,2018-26855,1,0,0900006483987c31 FDA-2015-D-4750-0022,FDA,FDA-2015-D-4750,"Draft Guidance for Industry The ""Deemed to be a License"" Provision of the BPCI Act Questions and Answers Guidance for Industry",Other,Guidance,2018-12-12T05:00:00Z,2018,12,2018-12-12T05:00:00Z,2019-02-12T04:59:59Z,2024-11-12T22:52:01Z,,1,0,0900006483988ea0 FDA-2015-D-4750-0020,FDA,FDA-2015-D-4750,"Interpretation of the ‘‘Deemed To Be a License’’ Provision of the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability",Notice,Notice of Availability,2018-12-12T05:00:00Z,2018,12,2018-12-12T05:00:00Z,,2018-12-12T15:17:09Z,2018-26854,0,0,0900006483987aea FDA-2015-D-4750-0023,FDA,FDA-2015-D-4750,01-Final Guidance for Industry Interpretation of the Deemed to be a License Provision of the Biologics Price Competition and Innovation Act of 2009,Other,Guidance,2018-12-12T05:00:00Z,2018,12,2018-12-12T05:00:00Z,,2024-11-12T22:53:33Z,,1,0,0900006483988e9e FDA-2015-D-4750-0019,FDA,FDA-2015-D-4750,Memorandum of Meeting with Mylan,Other,Memorandum,2018-08-31T04:00:00Z,2018,8,2018-08-31T04:00:00Z,,2018-08-31T16:17:36Z,,0,0,09000064836875b1 FDA-2015-D-4750-0012,FDA,FDA-2015-D-4750,"Attachment 1 Draft Guidance "" Implementation of the ''Deemed to be a License'' Provision of the Biologics Price Competition and Innovation Act of 2009"" re: Comment from Biotechnology Innovation Organization",Supporting & Related Material,Background Material,2016-06-07T04:00:00Z,2016,6,,,2016-06-07T14:02:24Z,,0,0,0900006482018d24 FDA-2015-D-4750-0001,FDA,FDA-2015-D-4750,Implementation of the ‘‘Deemed To Be a License’’ Provision of the Biologics Price Competition and Innovation Act of 2009; Draft Guidance for Industry; Availability and Request for Comments,Notice,Notice of Availability,2016-03-14T04:00:00Z,2016,3,2016-03-14T04:00:00Z,2016-05-14T03:59:59Z,2016-05-14T04:00:39Z,2016-05626,0,0,0900006481ebf885 FDA-2015-D-4750-0002,FDA,FDA-2015-D-4750,Draft Guidance for Industry: Implementation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009,Other,Guidance,2016-03-14T04:00:00Z,2016,3,2016-03-14T04:00:00Z,,2024-11-12T05:56:21Z,,1,0,0900006481ebffbd