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withdrawn,object_id FDA-2009-D-0461-0100,FDA,FDA-2009-D-0461,Format and Content of a Risk Evaluation and Mitigation Strategy Document; Guidance for Industry; Availability,Notice,Notice of Data Availability,2023-01-05T05:00:00Z,2023,1,2023-01-05T05:00:00Z,,2023-01-05T13:06:16Z,2022-28602,0,0,090000648558aa6c FDA-2009-D-0461-0101,FDA,FDA-2009-D-0461,Format and Content of a REMS Document Guidance for Industry,Other,Guidance,2023-01-05T05:00:00Z,2023,1,2023-01-05T05:00:00Z,,2024-11-12T23:50:24Z,,1,0,090000648558b3d9 FDA-2009-D-0461-0071,FDA,FDA-2009-D-0461,Format and Content of a REMS Document Guidance for Industry,Other,Guidance,2017-10-12T04:00:00Z,2017,10,2017-10-12T04:00:00Z,,2024-11-07T01:18:09Z,,1,0,0900006482bc1d70 FDA-2009-D-0461-0070,FDA,FDA-2009-D-0461,"Format and Content of a Risk Evaluation and Mitigation Strategy Document; Revised Draft Guidance for Industry; Availability",Notice,Notice of Availability,2017-10-12T04:00:00Z,2017,10,2017-10-12T04:00:00Z,2017-12-12T04:59:59Z,2017-12-12T02:03:04Z,2017-22050,0,0,0900006482bc0c32 FDA-2009-D-0461-0068,FDA,FDA-2009-D-0461,Novartis Pharmaceuticals Corporation (NPC) - Supplement,Other,SUP-Supplement,2010-10-21T04:00:00Z,2010,10,2010-10-21T04:00:00Z,,2013-07-27T23:35:13Z,,0,0,0900006480b73fde FDA-2009-D-0461-0040,FDA,FDA-2009-D-0461,Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period,Notice,NM-Notice of Meeting,2010-06-17T04:00:00Z,2010,6,2010-06-17T04:00:00Z,2010-09-01T03:59:59Z,2010-10-29T01:10:10Z,2010-14547,0,0,0900006480b041b2 FDA-2009-D-0461-0015,FDA,FDA-2009-D-0461,See FDA-2009-D-0461-0026,Supporting & Related Material,,2009-12-30T00:00:00Z,2009,12,,,2013-07-29T17:10:22Z,,0,1,0900006480a70e27 FDA-2009-D-0461-0002,FDA,FDA-2009-D-0461,"Guidance for Industry Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications",Other,GDL-Guidance (Supporting and Related Materials),2009-10-01T04:00:00Z,2009,10,2009-10-01T04:00:00Z,2009-12-31T04:59:59Z,2009-10-01T18:24:50Z,,0,0,0900006480a35aeb FDA-2009-D-0461-0001,FDA,FDA-2009-D-0461,"Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies, REMS Assessments, and Proposed REMS Modifications",Notice,NAD-Notice of Availability of Data,2009-10-01T04:00:00Z,2009,10,2009-10-01T04:00:00Z,2009-12-31T04:59:59Z,2009-10-01T17:52:42Z,E9-23616,0,0,0900006480a34d5a