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withdrawn,object_id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-1998-D-0025-0036,FDA,FDA-1998-D-0025,Guidance on Current Good Manufacturing Practice for Positron Emission Tomography Drugs; Availability,Notice,NAD-Notice of Availability of Data,2009-12-10T05:00:00Z,2009,12,2009-12-10T05:00:00Z,,2024-11-12T04:49:38Z,E9-29286,1,0,0900006480a6845a
FDA-1998-D-0025-0037,FDA,FDA-1998-D-0025,Guidance on Pet Drugs --- Current Good Manufacturing Practice (CGMP) - GDL,Other,GDL-Guidance (Supporting and Related Materials),2009-12-10T05:00:00Z,2009,12,2009-12-10T05:00:00Z,,2024-11-07T22:11:10Z,,1,0,0900006480a686eb
FDA-1998-D-0025-0035,FDA,FDA-1998-D-0025,"FDA/CDER Public Meeting on Current Good Manufacturing Practices Regulation and Guidance for PET Drugs, May 21, 2002 - Transcript",Other,TR-Transcript,2009-05-04T04:00:00Z,2009,5,2009-05-04T04:00:00Z,,2013-08-11T04:18:35Z,,0,0,0900006480564782
FDA-1998-D-0025-0030,FDA,FDA-1998-D-0025,"Informal Discussion Between the Institute for Clinical PET and FDA - ""Discussion of Literature Review of Safety and Efficacy Data for PET: O-Water and F-Fluorodopa, July 28, 2000""] - Participant List",Other,LST-List,2009-05-04T04:00:00Z,2009,5,2009-05-04T04:00:00Z,,2009-05-04T06:20:04Z,,0,0,0900006480564711
FDA-1998-D-0025-0031,FDA,FDA-1998-D-0025,"Institute for Clinical PET - ""F-DOPA [Master Index]"" - List",Other,LST-List,2009-05-04T04:00:00Z,2009,5,2009-05-04T04:00:00Z,,2013-08-11T04:18:35Z,,0,0,0900006480564713
FDA-1998-D-0025-0029,FDA,FDA-1998-D-0025,"Agenda - Informal Discussion Between the Institute for Clinical PET and FDA - ""Discussion of Literature Review of Safety and Efficacy Data for PET: O-Water and F-Fluorodopa, July 28, 2000"" - List",Other,LST-List,2009-05-04T04:00:00Z,2009,5,2009-05-04T04:00:00Z,,2013-07-27T21:41:01Z,,0,0,090000648056470e
FDA-1998-D-0025-0033,FDA,FDA-1998-D-0025,"Informal Discussion Between the Institute for Clinical PET and FDA, July 28, 2000 (Pages 1-100) - Transcript",Other,TR-Transcript,2009-05-04T04:00:00Z,2009,5,2009-05-04T04:00:00Z,,2013-07-27T21:41:01Z,,0,0,090000648056471e
FDA-1998-D-0025-0032,FDA,FDA-1998-D-0025,"Institute for Clinical PET - ""O-Water Literatures - 2nd Cycle Master Index, July 25, 2000"" - List",Other,LST-List,2009-05-04T04:00:00Z,2009,5,2009-05-04T04:00:00Z,,2009-05-04T06:20:07Z,,0,0,0900006480564716
FDA-1998-D-0025-0034,FDA,FDA-1998-D-0025,"Informal Discussion Between the Institute for Clinical PET and FDA, July 28, 2000 (Pages 101-188) - Transcript",Other,TR-Transcript,2009-05-04T04:00:00Z,2009,5,2009-05-04T04:00:00Z,,2013-08-11T04:18:35Z,,0,0,0900006480564719
FDA-1998-D-0025-0011,FDA,FDA-1998-D-0025,"FDA/CDER to Institute for Clinical PET - [Meeting Between the Institute for Clinical PET and FDA Staff On Approval Procedures for PET Drugs, February 18-19, 1999] - Letter",Other,LST-List,2009-05-03T04:00:00Z,2009,5,2009-05-03T04:00:00Z,,2013-07-27T21:41:00Z,,0,0,0900006480564630
FDA-1998-D-0025-0012,FDA,FDA-1998-D-0025,"FDA/CDER to Institute for Clinical PET - ""Existing Reglatory Framework for Drug Approval"" - [Meeting Between the Institute for Clinical PET and FDA Staff On Approval Procedures for PET Drugs, February 18-19, 1999] - Overview",Other,LST-List,2009-05-03T04:00:00Z,2009,5,2009-05-03T04:00:00Z,,2013-07-27T21:41:00Z,,0,0,0900006480564632
FDA-1998-D-0025-0017,FDA,FDA-1998-D-0025,"Meeting Between the Institute for Clinical PET and FDA Staff On Approval Procedures for PET Drugs, February 19, 1999 - Transcript",Other,TR-Transcript,2009-05-03T04:00:00Z,2009,5,2009-05-03T04:00:00Z,,2013-08-11T04:18:35Z,,0,0,0900006480564651
FDA-1998-D-0025-0015,FDA,FDA-1998-D-0025,"Draft Model Appliction to Manufacture Fludeoxyglucose F-18 Unjection for Marketing"" - [Meeting Between the Institute for Clinical PET and FDA Staff On Approval Procedures for PET Drugs, February 18-19, 1999]",Other,LST-List,2009-05-03T04:00:00Z,2009,5,2009-05-03T04:00:00Z,,2009-05-04T01:18:32Z,,0,0,090000648056463f
FDA-1998-D-0025-0006,FDA,FDA-1998-D-0025,FDA/CDER Response to UCLA School of Medicine - Letter,Other,LET-Letter,2009-05-03T04:00:00Z,2009,5,2009-05-03T04:00:00Z,,2013-07-27T21:41:00Z,,0,0,090000648056460e
FDA-1998-D-0025-0020,FDA,FDA-1998-D-0025,"Supplement to Agenda - ""Meeting Between the Institute for Clinical PET and FDA Staff On Approval Procedures for PET Drugs, February 19, 1999"" - Participant List",Other,SUP-Supplement,2009-05-03T04:00:00Z,2009,5,2009-05-03T04:00:00Z,,2009-05-04T02:21:08Z,,0,0,0900006480564658
FDA-1998-D-0025-0009,FDA,FDA-1998-D-0025,FDA/CDER and Institute for Clinical PET - TeleConference Call Minutes,Other,MT-Memorandum of Telephone Conversation,2009-05-03T04:00:00Z,2009,5,2009-05-03T04:00:00Z,,2013-07-27T21:41:00Z,,0,0,0900006480564624
FDA-1998-D-0025-0021,FDA,FDA-1998-D-0025,"Meeting Between FDA/CDER and Institute for Clinical PET - ""Informal Discussion of PET Drugs: Development of Current Good Manufacturing Practices and Approval Procedures"" - List",Other,LST-List,2009-05-03T04:00:00Z,2009,5,2009-05-03T04:00:00Z,,2013-08-11T02:45:19Z,,0,0,09000064805646ed
FDA-1998-D-0025-0028,FDA,FDA-1998-D-0025,"Informal Discussion Between the Institute for Clinical PET and FDA Development of Current Good Manufacturing Practices and Approval Procedures for PET Drugs, September 28, 1999 "" - Transcript (Pages 201-243)",Other,TR-Transcript,2009-05-03T04:00:00Z,2009,5,2009-05-03T04:00:00Z,,2009-05-04T02:24:34Z,,0,0,0900006480564706
FDA-1998-D-0025-0026,FDA,FDA-1998-D-0025,"Model Application to Manufacture Sodium Fluoride F-18 Injection for Marketing, September 20, 1999 - [Informal Discussion Between the Institute for Clinical PET and FDA Development of Current Good Manufacturing Practices and Approval Procedures for PET Drugs, September 28, 1999 "" - Transcript]",Supporting & Related Material,LST- List,2009-05-03T04:00:00Z,2009,5,,,2009-05-04T02:31:48Z,,0,0,09000064805646e9
FDA-1998-D-0025-0005,FDA,FDA-1998-D-0025,FDA/CDER Response to U.S. Pharmacopeial (USP) - Letter,Other,LET-Letter,2009-05-03T04:00:00Z,2009,5,2009-05-03T04:00:00Z,,2013-07-27T21:40:59Z,,0,0,090000648056460b
FDA-1998-D-0025-0007,FDA,FDA-1998-D-0025,FDA/CDER and Institute for Clinical PET - Conference Call Minutes,Other,MM-Memorandum of Meeting,2009-05-03T04:00:00Z,2009,5,2009-05-03T04:00:00Z,,2013-08-11T02:45:19Z,,0,0,0900006480564612
FDA-1998-D-0025-0024,FDA,FDA-1998-D-0025,"Informal Discussion Between the Institute for Clinical PET and FDA Development of Current Good Manufacturing Practices and Approval Procedures for PET Drugs, September 28, 1999 "" - Transcript (Pages 101-200)",Other,TR-Transcript,2009-05-03T04:00:00Z,2009,5,2009-05-03T04:00:00Z,,2013-07-27T21:41:01Z,,0,0,0900006480564709
FDA-1998-D-0025-0013,FDA,FDA-1998-D-0025,"Draft Outline for Positron Emission Tomography (PET) CGMPs - [Meeting Between the Institute for Clinical PET and FDA Staff On Approval Procedures for PET Drugs, February 18-19, 1999]",Other,LST-List,2009-05-03T04:00:00Z,2009,5,2009-05-03T04:00:00Z,,2009-05-04T01:18:29Z,,0,0,0900006480564639
FDA-1998-D-0025-0008,FDA,FDA-1998-D-0025,FDA/CDER Response to UCLA School of Medicine - Letter,Other,LET-Letter,2009-05-03T04:00:00Z,2009,5,2009-05-03T04:00:00Z,,2013-07-28T01:45:18Z,,0,0,0900006480564615
FDA-1998-D-0025-0023,FDA,FDA-1998-D-0025,"Informal Discussion Between the Institute for Clinical PET and FDA Development of Current Good Manufacturing Practices and Approval Procedures for PET Drugs, September 28, 1999 "" - Transcript (Pages 1-100)",Other,TR-Transcript,2009-05-03T04:00:00Z,2009,5,2009-05-03T04:00:00Z,,2013-07-27T21:41:01Z,,0,0,0900006480564701
FDA-1998-D-0025-0027,FDA,FDA-1998-D-0025,"Model Application to Manufacture Fludeoxyglucose F-18 Injection for Marketing, September 20, 1999 - [Informal Discussion Between the Institute for Clinical PET and FDA Development of Current Good Manufacturing Practices and Approval Procedures for PET Drugs, September 28, 1999 "" - Transcript]",Supporting & Related Material,LST- List,2009-05-03T04:00:00Z,2009,5,,,2009-05-04T02:30:32Z,,0,0,09000064805646f6
FDA-1998-D-0025-0016,FDA,FDA-1998-D-0025,"Meeting Between the Institute for Clinical PET and FDA Staff On Approval Procedures for PET Drugs, February 18, 1999 - Transcript",Other,TR-Transcript,2009-05-03T04:00:00Z,2009,5,2009-05-03T04:00:00Z,,2013-07-27T21:41:00Z,,0,0,090000648056464b
FDA-1998-D-0025-0022,FDA,FDA-1998-D-0025,"Agenda - ""Informal Discussion Between the Institute for Clinical PET and FDA Development of Current Good Manufacturing Practices and Approval Procedures for PET Drugs, September 28, 1999 "" - List",Other,LST-List,2009-05-03T04:00:00Z,2009,5,2009-05-03T04:00:00Z,,2009-05-04T02:21:11Z,,0,0,09000064805646fa
FDA-1998-D-0025-0014,FDA,FDA-1998-D-0025,"Agenda - ""Meeting Between the Institute for Clinical PET and FDA Staff On Approval Procedures for PET Drugs, February 18-19, 1999"" - List",Other,LST-List,2009-05-03T04:00:00Z,2009,5,2009-05-03T04:00:00Z,,2013-07-28T01:45:18Z,,0,0,090000648056463d
FDA-1998-D-0025-0025,FDA,FDA-1998-D-0025,"Model Application to Manufacture Ammonia N-13 Injection for Marketing, September 20, 1999 - [Informal Discussion Between the Institute for Clinical PET and FDA Development of Current Good Manufacturing Practices and Approval Procedures for PET Drugs, September 28, 1999 "" - Transcript]",Supporting & Related Material,LST- List,2009-05-03T04:00:00Z,2009,5,,,2009-05-04T02:26:53Z,,0,0,09000064805646e7
FDA-1998-D-0025-0004,FDA,FDA-1998-D-0025,Draft Guidance an Current Good Manufacturing Practice for Positron Emission Tomography Drug Products; Availability [NAD1],Notice,NAD-Notice of Availability of Data,2009-05-03T04:00:00Z,2009,5,2009-05-03T04:00:00Z,2002-06-06T03:59:59Z,2009-05-04T06:59:32Z,,0,0,090000648056473f
FDA-1998-D-0025-0018,FDA,FDA-1998-D-0025,"Attachment - F-18 FDG PET in Onocology Safety and Effectiveness Review - [Meeting Between the Institute for Clinical PET and FDA Staff On Approval Procedures for PET Drugs, February 18-19, 1999]",Supporting & Related Material,LST- List,2009-05-03T04:00:00Z,2009,5,,,2009-05-04T01:18:46Z,,0,0,0900006480564642
FDA-1998-D-0025-0019,FDA,FDA-1998-D-0025,"FDA/CDER to Institute for Clinical PET - ""Outline of Existing Reglatory Framework for Drug Approval"" - [Meeting Between the Institute for Clinical PET and FDA Staff On Approval Procedures for PET Drugs, February 18-19, 1999] - Outline",Other,LST-List,2009-05-03T04:00:00Z,2009,5,2009-05-03T04:00:00Z,,2009-05-04T01:20:00Z,,0,0,0900006480564647
FDA-1998-D-0025-0010,FDA,FDA-1998-D-0025,"Institute for Clinical Pet and FDA/CDER - ""Informal Discussion of Literature Reviews of Safety and Efficacy For FDG Oncology Indications; Approval Procedure Development Update.... February 18-19, 1999"" - Memorandum",Other,M-Memorandum,2009-05-03T04:00:00Z,2009,5,2009-05-03T04:00:00Z,,2013-07-27T21:41:00Z,,0,0,0900006480564629
FDA-1998-D-0025-0001,FDA,FDA-1998-D-0025,Draft Guidance an Current Good Manufacturing Practice for Positron Emission Tomography Drug Products; Availability [NAD2],Notice,NAD-Notice of Availability of Data,2005-09-20T04:00:00Z,2005,9,2005-09-15T04:00:00Z,2005-12-20T04:59:59Z,2009-05-04T06:59:04Z,,0,0,090000648056458e
FDA-1998-D-0025-0002,FDA,FDA-1998-D-0025,Guidance PET Drug Products – Current Good Manufacturing Practice (CGMP) - Draft Guidance,Supporting & Related Material,GDL-Guidance,2005-09-20T04:00:00Z,2005,9,,,2009-05-04T07:25:51Z,,0,0,0900006480564784
FDA-1998-D-0025-0003,FDA,FDA-1998-D-0025,Guidance PET Drug Products – Current Good Manufacturing Practice (CGMP) - Draft Guidance,Other,GDL-Guidance (Supporting and Related Materials),2005-09-20T04:00:00Z,2005,9,,,2009-05-04T07:23:27Z,,0,0,0900006480564787