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34 rows where docket_id = "FDA-1998-D-0025" and posted_year = 2009 sorted by posted_date descending
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| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 | Section 121 Positron Emission Tomography (PET) FDAMA 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 |
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CREATE TABLE documents (
id TEXT PRIMARY KEY,
agency_id TEXT,
docket_id TEXT REFERENCES dockets(id),
title TEXT,
document_type TEXT,
subtype TEXT,
posted_date TEXT,
posted_year INTEGER,
posted_month INTEGER,
comment_start_date TEXT,
comment_end_date TEXT,
last_modified TEXT,
fr_doc_num TEXT,
open_for_comment INTEGER,
withdrawn INTEGER,
object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);