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withdrawn,object_id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-0605-0060,FDA,FDA-2011-D-0605,Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies; Draft Guidance for Industry,Other,Guidance,2025-11-20T05:00:00Z,2025,11,2025-11-20T05:00:00Z,2026-01-21T04:59:59Z,2026-01-24T13:16:32Z,,1,0,09000064b9088de2
FDA-2011-D-0605-0059,FDA,FDA-2011-D-0605,Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2025-11-20T05:00:00Z,2025,11,2025-11-20T05:00:00Z,,2025-11-20T19:15:15Z,2025-20380,0,0,09000064b908a856
FDA-2011-D-0605-0054,FDA,FDA-2011-D-0605,Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Guidance for Industry; Availability,Notice,Notice of Availability,2015-04-30T04:00:00Z,2015,4,2015-04-30T04:00:00Z,,2025-11-20T19:18:14Z,2015-10062,0,0,0900006481ac4844
FDA-2011-D-0605-0055,FDA,FDA-2011-D-0605,Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Guidance for Industry,Other,Guidance,2015-04-28T04:00:00Z,2015,4,2015-04-28T04:00:00Z,,2025-11-05T10:00:14Z,,1,0,0900006481ac5991
FDA-2011-D-0605-0053,FDA,FDA-2011-D-0605,See FDA-2011-D-0618-0068,Supporting & Related Material,,2012-05-31T00:00:00Z,2012,5,,,2012-06-01T15:50:21Z,,0,1,090000648101d5c2
FDA-2011-D-0605-0033,FDA,FDA-2011-D-0605,"Merck & Co., Inc. - Comment re FDA-2011-D-0605-0032",Supporting & Related Material,Reference (external attachments),2012-04-16T04:00:00Z,2012,4,,,2012-04-16T20:55:45Z,,0,0,0900006480ff1e76
FDA-2011-D-0605-0002,FDA,FDA-2011-D-0605,Draft Guidance for Industry on Scientific Considerations in Demonstrating Biosimilarity to Reference Product,Other,Guidance,2012-02-15T05:00:00Z,2012,2,2012-02-15T05:00:00Z,,2019-06-18T15:48:59Z,,0,0,0900006480fb703a
FDA-2011-D-0605-0001,FDA,FDA-2011-D-0605,Draft Guidance for Industry on Scientific Considerations in Demonstrating Biosimilarity to Reference Product,Notice,Notice of Availability,2012-02-15T05:00:00Z,2012,2,2012-02-15T05:00:00Z,2012-04-17T03:59:59Z,2012-05-10T12:01:59Z,2012-03552,0,0,0900006480fb721e