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withdrawn,object_id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-2009-D-0539-0054,FDA,FDA-2009-D-0539,"Immunogenicity Testing of Therapeutic Protein Products—Developing and Validating Assays for Anti-Drug Antibody Detection; Guidance for
Industry; Availability",Notice,Notice of Availability,2019-02-01T05:00:00Z,2019,2,2019-02-01T05:00:00Z,,2019-02-01T14:56:05Z,2019-00666,0,0,0900006483a32a52
FDA-2009-D-0539-0055,FDA,FDA-2009-D-0539,"Immunogenicity Testing of Therapeutic Protein Products - Developing and Validating Assays for Anti-Drug Antibody Detection; Guidance for
Industry; Availability",Other,Guidance,2019-02-01T05:00:00Z,2019,2,2019-02-01T05:00:00Z,,2024-11-12T22:54:51Z,,1,0,0900006483a33009
FDA-2009-D-0539-0024,FDA,FDA-2009-D-0539,Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products Guidance for Industry,Other,Guidance,2016-04-26T04:00:00Z,2016,4,2016-04-26T04:00:00Z,,2019-06-18T16:22:13Z,,0,0,0900006481f902a5
FDA-2009-D-0539-0023,FDA,FDA-2009-D-0539,Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products; Revised Draft Guidance for Industry; Availability,Notice,Notice of Availability,2016-04-25T04:00:00Z,2016,4,2016-04-25T04:00:00Z,2016-06-25T03:59:59Z,2016-06-25T13:00:11Z,2016-09449,0,0,0900006481f89040
FDA-2009-D-0539-0002,FDA,FDA-2009-D-0539,Guidance for Industry Assay Development for Immunogenicity Testing of Therapeutic Proteins; Guidance,Other,Guidance,2009-12-04T05:00:00Z,2009,12,2009-12-04T05:00:00Z,2010-02-03T04:59:59Z,2016-04-11T14:26:47Z,,0,0,0900006480a6350f
FDA-2009-D-0539-0001,FDA,FDA-2009-D-0539,Draft Guidance for Industry on Assay Development for Immunogenicity Testing of Therapeutic Proteins; Availability,Notice,Notice of Availability,2009-12-04T05:00:00Z,2009,12,2009-12-04T05:00:00Z,2010-02-03T04:59:59Z,2016-04-11T14:24:08Z,E9-28960,0,0,0900006480a62b67