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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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37 rows where agency_id = "FDA" and docket_id = "FDA-1998-D-0025" sorted by posted_date descending

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  • FDA · 37 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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
FDA-1998-D-0025-0001 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 [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 Section 121 Positron Emission Tomography (PET) FDAMA 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 Section 121 Positron Emission Tomography (PET) FDAMA 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

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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);