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withdrawn,object_id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-2011-D-0611-0091,FDA,FDA-2011-D-0611,Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act; Guidance for Industry; Draft Guidance,Other,Guidance,2023-09-15T00:00:00Z,2023,9,2023-09-15T00:00:00Z,,2025-05-06T01:33:49Z,,1,0,0900006485fb1ea4
FDA-2011-D-0611-0089,FDA,FDA-2011-D-0611,Final Guidance Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry,Other,Guidance,2021-09-20T04:00:00Z,2021,9,2021-09-20T04:00:00Z,,2021-09-20T15:02:28Z,,0,0,0900006484d94970
FDA-2011-D-0611-0088,FDA,FDA-2011-D-0611,"Questions and Answers on BiosimilarDevelopment and the Biologics Price
Competition and Innovation Act of 2009; Guidance for Industry;
Availability",Notice,Notice of Availability,2021-09-20T04:00:00Z,2021,9,2021-09-20T04:00:00Z,,2021-09-21T00:59:26Z,2021-20255,0,0,0900006484d93980
FDA-2011-D-0611-0082,FDA,FDA-2011-D-0611,Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act Guidance for Industry,Other,Guidance,2020-11-20T05:00:00Z,2020,11,2020-11-20T05:00:00Z,,2024-11-06T23:43:39Z,,1,0,090000648496c7ea
FDA-2011-D-0611-0081,FDA,FDA-2011-D-0611,Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2020-11-20T05:00:00Z,2020,11,2020-11-20T05:00:00Z,2021-01-20T04:59:59Z,2021-01-21T02:00:45Z,2020-25606,0,0,090000648496ac54
FDA-2011-D-0611-0080,FDA,FDA-2011-D-0611,Memorandum of Meeting to Discuss Post-Licensure Biosimilar Labeling Changes,Other,Memorandum,2019-07-18T04:00:00Z,2019,7,2019-07-18T04:00:00Z,,2019-07-18T15:21:39Z,,0,0,0900006483d9d811
FDA-2011-D-0611-0065,FDA,FDA-2011-D-0611,"New and Revised Draft Q&As on Biosimilar Development and the
Biologics Price Competition and Innovation Act (Revision 2); Draft
Guidance for Industry; Availability",Notice,Notice of Availability,2018-12-12T05:00:00Z,2018,12,2018-12-12T05:00:00Z,2019-02-12T04:59:59Z,2019-11-18T16:51:35Z,2018-26852,0,0,0900006483987c81
FDA-2011-D-0611-0064,FDA,FDA-2011-D-0611,"Biosimilars: Questions and Answers on Biosimilar Development and 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,,2018-12-12T15:04:52Z,2018-26853,0,0,0900006483987c7c
FDA-2011-D-0611-0067,FDA,FDA-2011-D-0611,Questions and Answers on Biosimilar Development and the BPCI Act; Guidance for Industry,Other,Guidance,2018-12-11T05:00:00Z,2018,12,2018-12-11T05:00:00Z,,2024-11-12T22:53:26Z,,1,0,0900006483988a7d
FDA-2011-D-0611-0066,FDA,FDA-2011-D-0611,"New and Revised Draft Q&As on Biosimilar Development and the BPCI
Act (Revision 2); Guidance for Industry; Draft Guidance",Other,Guidance,2018-12-11T05:00:00Z,2018,12,2018-12-11T05:00:00Z,,2024-11-12T22:53:26Z,,1,0,0900006483988a81
FDA-2011-D-0611-0056,FDA,FDA-2011-D-0611,Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Draft Guidance for Industry,Other,Guidance,2015-05-13T04:00:00Z,2015,5,2015-05-13T04:00:00Z,,2019-11-18T16:53:10Z,,0,0,0900006481addc66
FDA-2011-D-0611-0055,FDA,FDA-2011-D-0611,Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2015-05-13T04:00:00Z,2015,5,2015-05-13T04:00:00Z,2015-07-14T03:59:59Z,2015-07-14T01:30:24Z,2015-11528,0,0,0900006481addda4
FDA-2011-D-0611-0054,FDA,FDA-2011-D-0611,"Biosimilars: Questions and Answers Regarding Implementation of the
Biologics Price Competition and Innovation Act of 2009; Guidance for
Industry",Other,Guidance,2015-04-30T04:00:00Z,2015,4,2015-04-30T04:00:00Z,,2019-11-18T16:52:55Z,,0,0,0900006481ac56a1
FDA-2011-D-0611-0053,FDA,FDA-2011-D-0611,"Biosimilars: Questions and Answers Regarding Implementation of the
Biologics Price Competition and Innovation Act of 2009; Guidance for
Industry; Availability",Notice,Notice of Availability,2015-04-30T04:00:00Z,2015,4,2015-04-30T04:00:00Z,,2015-04-30T15:38:03Z,2015-10064,0,0,0900006481ac4d35
FDA-2011-D-0611-0001,FDA,FDA-2011-D-0611,Draft Guidance for Industry on Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Availability,Notice,Notice of Availability,2012-02-15T05:00:00Z,2012,2,2012-02-15T05:00:00Z,2012-04-17T03:59:59Z,2012-05-12T12:01:36Z,2012-03549,0,0,0900006480fb722f
FDA-2011-D-0611-0002,FDA,FDA-2011-D-0611,Guidance for Industry on Implementation of Biologics Price Competition and Innovation Act of 2009; Draft Guidance,Other,Guidance,2012-02-15T05:00:00Z,2012,2,2012-02-15T05:00:00Z,,2019-11-18T16:52:17Z,,0,0,0900006480fb7017