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withdrawn,object_id FDA-2010-D-0482-0033,FDA,FDA-2010-D-0482,"Guidances for Industry and Investigators; on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/ Bioequivalence Studies, and a Small Entity Compliance Guide; Availability",Notice,Notice of Availability,2012-12-20T05:00:00Z,2012,12,2012-12-20T05:00:00Z,,2019-08-22T20:02:45Z,2012-30651,0,0,0900006481193abb FDA-2010-D-0482-0034,FDA,FDA-2010-D-0482,Guidance for Industry and Investigators Safety Reporting Requirements for INDs and BA BE Studies,Other,Guidance,2012-12-20T05:00:00Z,2012,12,2012-12-20T05:00:00Z,,2024-11-12T05:10:37Z,,1,0,0900006481193beb FDA-2010-D-0482-0035,FDA,FDA-2010-D-0482,"Guidances for Industry and Investigators; on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/ Bioequivalence Studies, Small Entity Compliance Guide",Other,Guidance,2012-12-20T05:00:00Z,2012,12,2012-12-20T05:00:00Z,,2019-08-22T20:06:38Z,,0,0,0900006481193bed FDA-2010-D-0482-0032,FDA,FDA-2010-D-0482,"Minute of the FDA-PhRMA Dialogue, dated September 9, 2011",Other,Minutes,2012-04-13T04:00:00Z,2012,4,2012-04-13T04:00:00Z,,2019-08-22T20:02:30Z,,0,0,0900006480feea00 FDA-2010-D-0482-0029,FDA,FDA-2010-D-0482,Guidance for Industry and Investigators on Enforcement of Safety Reporting Requirements: Investigational New Drug Applications and Bioavailability/Bioequivalence Studies; Availability,Notice,NAD-Notice of Availability of Data,2011-06-07T04:00:00Z,2011,6,2011-06-07T04:00:00Z,,2011-06-07T15:38:14Z,2011-13950,0,0,0900006480e3df14 FDA-2010-D-0482-0030,FDA,FDA-2010-D-0482,Guidance for Industry and Investigators on Enforcement of Safety Reporting Requirements: Investigational New Drug Applications and Bioavailability/Bioequivalence Studies,Other,GDL-Guidance,2011-06-07T04:00:00Z,2011,6,2011-06-07T04:00:00Z,,2019-08-22T20:03:09Z,,0,0,0900006480e3e2a5 FDA-2010-D-0482-0027,FDA,FDA-2010-D-0482,FDA/PhRMA Meeting Minutes,Other,MM-Memorandum of Meeting,2011-05-05T04:00:00Z,2011,5,2011-05-05T04:00:00Z,,2013-07-27T23:52:13Z,,0,0,0900006480c40227 FDA-2010-D-0482-0026,FDA,FDA-2010-D-0482,Pharmaceutical Research and Manufacturers of America (PhRMA) - Letter,Other,LET-Letter,2011-05-05T04:00:00Z,2011,5,2011-05-05T04:00:00Z,,2013-07-27T23:52:13Z,,0,0,0900006480c40225 FDA-2010-D-0482-0025,FDA,FDA-2010-D-0482,New IND Safety Reporting Requirements,Supporting & Related Material,N-Notice (Supporting and Related Material),2011-03-28T04:00:00Z,2011,3,,,2011-03-28T13:20:19Z,,0,0,0900006480c11d39 FDA-2010-D-0482-0020,FDA,FDA-2010-D-0482,Safety Reporting Requirements for INDs and BA/BE Studies; Draft Guidance,Other,GDL-Guidance (Supporting and Related Materials),2011-01-21T05:00:00Z,2011,1,2011-01-21T05:00:00Z,,2017-12-06T02:02:21Z,,0,0,0900006480b63418 FDA-2010-D-0482-0001,FDA,FDA-2010-D-0482,Draft Guidance for Industry and Investigators: Safety Reporting Requirements for Investigational New Drug Applications andBioavailability/Bioequivalence Studies; Availability,Notice,GDL-Guidance,2010-09-29T04:00:00Z,2010,9,2010-09-29T04:00:00Z,2010-12-29T04:59:59Z,2010-09-29T15:28:33Z,2010-24295,0,0,0900006480b63098