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withdrawn,object_id FDA-2000-D-1542-0012,FDA,FDA-2000-D-1542,Guidance on Positron Emission Tomography Drug Applications; Availability: Content and Format for New Drug Applications and Abbreviated New Drug Applications,Notice,Notice of Availability,2011-09-01T04:00:00Z,2011,9,2011-09-01T04:00:00Z,,2011-09-01T13:20:56Z,2011-22373,0,0,0900006480f0deb5 FDA-2000-D-1542-0013,FDA,FDA-2000-D-1542,Guidance PET Drug Applications - Content and Format for NDAs and ANDAs - Guidance,Other,Guidance,2011-09-01T04:00:00Z,2011,9,2011-09-01T04:00:00Z,,2011-09-01T13:37:32Z,,0,0,0900006480f0d014 FDA-2000-D-1542-0009,FDA,FDA-2000-D-1542,Attachment II - Sample Formats----- Form FDA 356h for Ammonia N 13 Injection Fludeoxyglucose F 18 Injection (FDG F 18) and Sodium Fluoride F 18 Injection,Other,GDL-Guidance (Supporting and Related Materials),2011-02-03T05:00:00Z,2011,2,2011-02-03T05:00:00Z,,2011-02-03T15:48:11Z,,0,0,0900006480bda036 FDA-2000-D-1542-0007,FDA,FDA-2000-D-1542,Guidance PET Drug Applications----- Content and Format for NDAs and ANDAs,Other,GDL-Guidance (Supporting and Related Materials),2011-02-03T05:00:00Z,2011,2,2011-02-03T05:00:00Z,2011-04-05T03:59:59Z,2011-02-03T15:48:07Z,,0,0,0900006480bda032 FDA-2000-D-1542-0006,FDA,FDA-2000-D-1542,"Draft Guidance on Positron Emission Tomography Drug Applications - Content and Format for New Drug Applications, and Abbreviated New Drug Applications; Availability",Notice,NAD-Notice of Availability of Data,2011-02-03T05:00:00Z,2011,2,2011-02-03T05:00:00Z,2011-04-05T03:59:59Z,2011-02-03T14:24:36Z,2011-2314,0,0,0900006480bda36d FDA-2000-D-1542-0008,FDA,FDA-2000-D-1542,"Attachment I - Sample Formats----- Chemistry, Manufacturing, and Controls (CMC) Section Ammonia N 13 Injection Fludeoxyglucose F 18 Injection (FDG F 18)",Other,GDL-Guidance (Supporting and Related Materials),2011-02-03T05:00:00Z,2011,2,2011-02-03T05:00:00Z,,2024-11-07T22:28:16Z,,1,0,0900006480bda034 FDA-2000-D-1542-0005,FDA,FDA-2000-D-1542,"Attachment I - Sample Formats—Application To Manufacture - Ammonia N 13 Injection Fludeoxyglucose F 18 Injection (FDG F 18) and Sodium Fluoride F 18 Injection Chemistry, Manufacturing, and Controls Section [FDA-2000-D-1542-0002]",Supporting & Related Material,GDL-Guidance,2009-11-16T05:00:00Z,2009,11,,,2009-11-16T20:09:17Z,,0,0,0900006480a5891e FDA-2000-D-1542-0001,FDA,FDA-2000-D-1542,Draft Guidance for Industry on the Content and Format of New Drug Applications and Abbreviated New Drug Applications for Certain Positron Emission Tomography Drug Products; Availability,Notice,NAD-Notice of Availability of Data,2009-11-16T05:00:00Z,2009,11,2009-11-16T05:00:00Z,2000-06-09T03:59:59Z,2009-11-16T19:37:14Z,,0,0,09000064804f9074 FDA-2000-D-1542-0002,FDA,FDA-2000-D-1542,Draft Guidance for Industry on the Content and Format of New Drug Applications and Abbreviated New Drug Applications for Certain Positron Emission Tomography Drug Products - Guidance,Other,GDL-Guidance (Supporting and Related Materials),2000-03-10T19:46:00Z,2000,3,2000-03-10T05:00:00Z,,2019-10-17T17:11:55Z,,0,0,09000064804f9073