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

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3,116 rows where agency_id = "FDA" and posted_year = 2004 sorted by posted_date descending

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document_type 5

posted_year 1

  • 2004 · 3,116 ✖

agency_id 1

  • FDA · 3,116 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2004-N-0318-0006 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 Transcript of November 18, 2004 Stakeholder Meeting Other Transcript(s) 2004-12-29T05:00:00Z 2004 12     2025-09-26T17:48:39Z   0 0 090000648047300c
FDA-2004-N-0318-0003 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 Transcript of November 18, 2004 Stakeholder Meeting Other Transcript(s) 2004-12-29T05:00:00Z 2004 12     2025-09-26T17:47:25Z   0 0 0900006480473009
FDA-2004-N-0318-0004 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 Transcript of November 18, 2004 Stakeholder Meeting Other Transcript(s) 2004-12-29T05:00:00Z 2004 12     2025-09-26T17:47:41Z   0 0 090000648047300a
FDA-2004-P-0401-0001 FDA Request the Commissioner of Food and Drugs re-evaluate FDA's policy concerning the marketing of 'authorized generic' versions of brand name prescription drugs. - CLOSED FDA-2004-P-0401 Acknowledgment Letter from FDA/CDER to Andrx Pharmaceuticals, Inc. Other Acknowledgement Letter/Receipt 2004-12-29T05:00:00Z 2004 12 2004-12-27T05:00:00Z   2025-03-28T01:00:45Z   0 0 09000064804744d0
FDA-2004-P-0401-0002 FDA Request the Commissioner of Food and Drugs re-evaluate FDA's policy concerning the marketing of 'authorized generic' versions of brand name prescription drugs. - CLOSED FDA-2004-P-0401 Acknowledgment Letter from FDA/CDER to Andrx Pharmaceuticals, Inc. Other Acknowledgement Letter/Receipt 2004-12-29T05:00:00Z 2004 12 2004-12-27T05:00:00Z   2025-03-27T21:26:48Z   0 0 09000064804744d6
FDA-2004-N-0318-0002 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 Transcript of November 18, 2004 Stakeholder Meeting Other Transcript(s) 2004-12-29T05:00:00Z 2004 12     2025-09-26T17:47:08Z   0 0 0900006480473008
FDA-2004-N-0318-0005 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 Transcript of November 18, 2004 Stakeholder Meeting Other Transcript(s) 2004-12-29T05:00:00Z 2004 12     2025-09-26T17:48:17Z   0 0 090000648047300b
FDA-2004-N-0318-0011 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 MDUFMA and the GMP Inspection Program Other Testimony 2004-12-29T00:00:00Z 2004 12     2025-04-30T16:56:03Z   0 0 0900006480473015
FDA-2004-N-0318-0012 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 BIMO and MDUFMA Other Testimony 2004-12-29T00:00:00Z 2004 12     2025-04-30T16:59:49Z   0 0 0900006480473016
FDA-2004-N-0318-0015 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 Inspection by Accredited persons (AP) Program Other Testimony 2004-12-29T00:00:00Z 2004 12     2025-04-30T17:15:34Z   0 0 0900006480473019
FDA-2004-N-0318-0014 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 CBER and MDUFMA Quantitative Goals Other Testimony 2004-12-29T00:00:00Z 2004 12     2025-04-30T17:11:01Z   0 0 0900006480473018
FDA-2004-N-0318-0009 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 Premarket Review Performance Goals Other Testimony 2004-12-29T00:00:00Z 2004 12     2025-04-30T18:51:39Z   0 0 0900006480473011
FDA-2004-N-0318-0013 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 Modular PMA Updates Other Testimony 2004-12-29T00:00:00Z 2004 12     2025-04-30T17:07:48Z   0 0 0900006480473017
FDA-2004-N-0318-0007 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 Agenda for November 18, 2004 Meeting Other List (LST) 2004-12-29T00:00:00Z 2004 12     2025-04-30T16:39:05Z   0 0 090000648047300d
FDA-2004-N-0318-0010 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 CBER MDUFMA Activity Other Testimony 2004-12-29T00:00:00Z 2004 12     2025-04-30T18:52:55Z   0 0 0900006480473012
FDA-2004-N-0318-0016 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 Reuse of Single Use Devices Other Testimony 2004-12-29T00:00:00Z 2004 12     2025-04-30T17:18:33Z   0 0 090000648047301b
FDA-2004-N-0318-0008 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 Financial Aspects of MDUFMA Other Testimony 2004-12-29T00:00:00Z 2004 12     2025-04-30T18:50:19Z   0 0 090000648047300e
FDA-2004-D-0118-0005 FDA Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: External Penile Rigidity Devices FDA-2004-D-0118 Guidance Supporting & Related Material GDL-Guidance 2004-12-28T05:00:00Z 2004 12     2008-04-12T00:34:19Z   0 0 090000648046fb07
FDA-2004-N-0308-0008 FDA Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Feeding Practices Study II FDA-2004-N-0308 Supporting Statement - List of Attachments Supporting & Related Material Background Material 2004-12-28T05:00:00Z 2004 12     2025-04-11T12:21:49Z   0 0 0900006480472ecb
FDA-2004-N-0308-0007 FDA Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Feeding Practices Study II FDA-2004-N-0308 Supporting Statement - Attachment C - Outline of Questionnaires with Indication of Whether Questions are the Same as the Previous Data Collection Supporting & Related Material Background Material 2004-12-28T05:00:00Z 2004 12     2025-04-11T12:19:30Z   0 0 0900006480472eca
FDA-2004-D-0118-0007 FDA Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: External Penile Rigidity Devices FDA-2004-D-0118 FDA Notice NAD-Notice of Availability of Data 2004-12-28T05:00:00Z 2004 12 2004-12-27T05:00:00Z 2005-12-29T04:59:59Z 2008-04-12T00:34:19Z   0 0 090000648046fb09
FDA-2004-D-0373-0004 FDA Guidance for Industry and FDA Staff on Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems; Availability FDA-2004-D-0373 Background Material Supporting & Related Material GDL-Guidance 2004-12-28T05:00:00Z 2004 12     2008-04-12T00:36:00Z   0 0 0900006480473724
FDA-2004-N-0308-0010 FDA Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Feeding Practices Study II FDA-2004-N-0308 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Infant Feeding Practices Study II Notice Notice of Approval 2004-12-28T05:00:00Z 2004 12     2025-04-09T20:03:59Z 04-28136 0 0 0900006480472ecd
FDA-2004-D-0118-0006 FDA Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: External Penile Rigidity Devices FDA-2004-D-0118 Guidance Supporting & Related Material GDL-Guidance 2004-12-28T05:00:00Z 2004 12     2008-04-12T00:34:19Z   0 0 090000648046fb08
FDA-2004-D-0373-0002 FDA Guidance for Industry and FDA Staff on Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems; Availability FDA-2004-D-0373 Background Material Supporting & Related Material GDL-Guidance 2004-12-28T05:00:00Z 2004 12     2008-04-12T00:36:00Z   0 0 0900006480473722
FDA-2004-N-0308-0004 FDA Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Feeding Practices Study II FDA-2004-N-0308 Supporting Statement for OMB Review - Infant Feeding Practices Study II Supporting & Related Material Background Material 2004-12-28T05:00:00Z 2004 12     2025-04-11T12:14:14Z   0 0 0900006480472ec7
FDA-2003-D-0031-0010 FDA Guidance for Industry on Pharmacogenomic Data Submissions FDA-2003-D-0031 FDA Notice NAL-Notice of Approval 2004-12-28T05:00:00Z 2004 12 2004-12-23T05:00:00Z   2008-04-12T00:54:06Z   0 0 09000064804815bc
FDA-2004-D-0373-0001 FDA Guidance for Industry and FDA Staff on Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems; Availability FDA-2004-D-0373 FDA Notice NAD-Notice of Availability of Data 2004-12-28T05:00:00Z 2004 12 2004-12-28T05:00:00Z 2005-12-29T04:59:59Z 2008-04-12T00:36:00Z   0 0 0900006480473721
FDA-2004-D-0373-0003 FDA Guidance for Industry and FDA Staff on Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems; Availability FDA-2004-D-0373 Background Material Supporting & Related Material GDL-Guidance 2004-12-28T05:00:00Z 2004 12     2008-04-12T00:36:00Z   0 0 0900006480473723
FDA-1998-N-0043-0003 FDA External Penile Rigidity Devices;Proposed Classification - Closed FDA-1998-N-0043 Gastroenterology-Urology Devices; Classification for External Penile Rigidity Devices Rule Final Rule 2004-12-28T05:00:00Z 2004 12     2024-09-17T12:34:00Z 04–28252 0 0 090000648056e637
FDA-2003-D-0031-0009 FDA Guidance for Industry on Pharmacogenomic Data Submissions FDA-2003-D-0031 Supporting Statement Supporting & Related Material SS-Supporting Statement 2004-12-28T05:00:00Z 2004 12     2008-04-12T00:54:07Z   0 0 09000064804815ba
FDA-2004-N-0308-0006 FDA Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Feeding Practices Study II FDA-2004-N-0308 Supporting Statement - List of Attachments Supporting & Related Material Background Material 2004-12-28T05:00:00Z 2004 12     2025-04-11T12:17:06Z   0 0 0900006480472ec9
FDA-2004-N-0054-0003 FDA Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment Request FDA-2004-N-0054 Medwatch - The FDA Safety Information and Adverse Event Reporting Program (Sample) Supporting & Related Material Background Material 2004-12-28T05:00:00Z 2004 12     2025-09-24T15:16:08Z   0 0 090000648046e8f8
FDA-2004-N-0054-0002 FDA Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment Request FDA-2004-N-0054 Medwatch - The FDA Safety Information and Adverse Event Reporting Program (Sample) Supporting & Related Material Background Material 2004-12-28T05:00:00Z 2004 12     2025-09-24T15:15:44Z   0 0 090000648046e8f7
FDA-2003-D-0031-0008 FDA Guidance for Industry on Pharmacogenomic Data Submissions FDA-2003-D-0031 Supporting Statement Supporting & Related Material SS-Supporting Statement 2004-12-28T05:00:00Z 2004 12     2008-04-12T00:54:07Z   0 0 09000064804815b9
FDA-2004-N-0569-0017 FDA Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting FDA-2004-N-0569 FDA Notice NEC-Notice of Extension 2004-12-28T05:00:00Z 2004 12 2004-12-27T05:00:00Z 2005-02-02T04:59:59Z 2008-04-12T00:46:19Z   0 0 0900006480483331
FDA-2004-N-0308-0005 FDA Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Feeding Practices Study II FDA-2004-N-0308 Supporting Statement for OMB Review - Infant Feeding Practices Study II Supporting & Related Material Background Material 2004-12-28T05:00:00Z 2004 12     2025-04-11T12:13:22Z   0 0 0900006480472ec8
FDA-2004-N-0254-0001 FDA Agency Information Collection Activities: Proposed Collection; Comment Request; Exports: Notification and Recordkeeping Requirements FDA-2004-N-0254 Agency Information Collection Activities; Proposed Collection; Comment Request; Exports: Notification and Recordkeeping Requirements Notice 60 Day Proposed Information Collection 2004-12-28T00:00:00Z 2004 12 2004-12-27T05:00:00Z 2005-02-26T04:59:59Z 2025-05-13T19:08:00Z 04-28137 0 0 0900006480471b8b
FDA-2004-N-0054-0001 FDA Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment Request FDA-2004-N-0054 Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: Food and Drug Administration Medical Products Reporting Program Notice 60 Day Proposed Information Collection 2004-12-28T00:00:00Z 2004 12 2004-12-27T05:00:00Z 2005-02-26T04:59:59Z 2025-05-13T09:00:41Z 04-28138 0 0 090000648046e8f4
FDA-2004-N-0497-0001 FDA Medical Devices; Obstetrical and Gynecological Devices; Classification of the Assisted Reproduction Laser System FDA-2004-N-0497 Medical Devices; Obstetrical and Gynecological Devices; Classification of the Assisted Reproduction Laser System Notice Notice of Final Rule 2004-12-28T00:00:00Z 2004 12     2025-05-12T19:12:18Z 04-28251 0 0 09000064804766b6
FDA-2004-N-0308-0009 FDA Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Feeding Practices Study II FDA-2004-N-0308 Supporting Statement - Attachment C - Outline of Questionnaires with Indication of Whether Questions are the Same as the Previous Data Collection Supporting & Related Material Background Material 2004-12-28T00:00:00Z 2004 12     2025-05-21T23:04:08Z   0 0 0900006480472ecc
FDA-1980-N-0049-0088 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review Other Report 2004-12-27T05:00:00Z 2004 12     2020-05-21T12:41:00Z   0 0 09000064805b99f4
FDA-1980-N-0049-0091 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review Other Report 2004-12-27T05:00:00Z 2004 12     2020-05-21T12:51:32Z   0 0 09000064805b99f7
FDA-1980-N-0049-0089 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review Other Report 2004-12-27T05:00:00Z 2004 12     2020-05-21T12:44:51Z   0 0 09000064805b99f5
FDA-2004-P-0345-0002 FDA ANDA Suitability for Acetaminophen, Butalbital and Caffeine Capsules USP, 300 mg/50 mg/40 mg-CLOSED FDA-2004-P-0345 Acknowledgment Letter from FDA DMB to Lachman Consultant Services, Inc. Other ACK-Acknowledgement Letter 2004-12-27T05:00:00Z 2004 12 2004-12-27T05:00:00Z   2025-03-27T20:51:13Z   0 0 09000064804734a7
FDA-2004-P-0096-0002 FDA ANDA Suitability for Acetaminophen, Butalbital Caffeine and Codeine Phosphate Capsules, 300 mg/50 mg/40 mg/30 mg-CLOSED FDA-2004-P-0096 Acknowledgment Letter from FDA/DMB to Lachman Consultant Services, Inc. Other Acknowledgement Letter/Receipt 2004-12-27T05:00:00Z 2004 12 2004-12-27T05:00:00Z   2025-03-27T19:34:05Z   0 0 090000648046f4ed
FDA-2004-P-0363-0001 FDA Request Immediate Recall of All Unapproved Methacholine Chloride Products-CLOSED FDA-2004-P-0363 Acknowledgment Letter from FDA/DMB to Methapharm, Inc. Other Acknowledgement Letter/Receipt 2004-12-27T05:00:00Z 2004 12 2004-12-27T05:00:00Z   2025-03-27T21:01:11Z   0 0 090000648047364f
FDA-1980-N-0049-0087 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review Other Report 2004-12-27T05:00:00Z 2004 12     2020-05-21T12:27:53Z   0 0 09000064805b99f3
FDA-1980-N-0049-0092 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review Other Report 2004-12-27T05:00:00Z 2004 12     2020-05-21T12:56:57Z   0 0 09000064805b99f8
FDA-1980-N-0049-0090 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review Other Report 2004-12-27T05:00:00Z 2004 12     2020-05-21T12:47:47Z   0 0 09000064805b99f6
FDA-2004-D-0182-0003 FDA Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information FDA-2004-D-0182 Guidance Supporting & Related Material GDL-Guidance 2004-12-27T05:00:00Z 2004 12     2008-04-12T00:34:48Z   0 0 0900006480470216
FDA-2004-D-0182-0001 FDA Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information FDA-2004-D-0182 FDA Notice NAD-Notice of Availability of Data 2004-12-27T05:00:00Z 2004 12 2004-12-20T05:00:00Z 2005-03-22T04:59:59Z 2008-04-12T00:34:48Z   0 0 0900006480470214
FDA-2004-D-0182-0002 FDA Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information FDA-2004-D-0182 Guidance Supporting & Related Material GDL-Guidance 2004-12-27T05:00:00Z 2004 12     2008-04-12T00:34:48Z   0 0 0900006480470215
FDA-2004-P-0345-0001 FDA ANDA Suitability for Acetaminophen, Butalbital and Caffeine Capsules USP, 300 mg/50 mg/40 mg-CLOSED FDA-2004-P-0345 Acknowledgment Letter from FDA/DMB to Lachman Consultant Services, Inc. Other Acknowledgement Letter/Receipt 2004-12-27T05:00:00Z 2004 12 2004-12-27T05:00:00Z   2025-03-27T20:38:11Z   0 0 09000064804734a2
FDA-2004-P-0096-0001 FDA ANDA Suitability for Acetaminophen, Butalbital Caffeine and Codeine Phosphate Capsules, 300 mg/50 mg/40 mg/30 mg-CLOSED FDA-2004-P-0096 Acknowledgment Letter from FDA/DMB to Lachman Consultant Services, Inc. Other Acknowledgement Letter/Receipt 2004-12-27T05:00:00Z 2004 12 2004-12-27T05:00:00Z   2025-03-27T19:29:18Z   0 0 090000648046f4e6
FDA-2004-D-0122-0003 FDA Guidance for Small Business Entities on Labeling Over-the-Counter Human Drug Products; Availability FDA-2004-D-0122 See FDA-2004-D-0122-0002 Supporting & Related Material GDL-Guidance 2004-12-23T05:00:00Z 2004 12     2009-05-11T15:47:27Z   0 0 090000648046fbc1
FDA-2004-M-0072-0001 FDA Premarket Approval for Sculptra - P030050 FDA-2004-M-0072 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applicatio11 Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-08-01T22:43:29Z 04-27387 0 0 090000648046ed12
FDA-2004-D-0122-0002 FDA Guidance for Small Business Entities on Labeling Over-the-Counter Human Drug Products; Availability FDA-2004-D-0122 Compliance Guidance for Small Business Entities on Labeling Over-the-Counter Human Drug Products; Draft Guidance Other GDL-Guidance (Supporting and Related Materials) 2004-12-23T05:00:00Z 2004 12     2013-08-11T04:06:32Z   0 0 090000648046fbbe
FDA-2002-N-0153-0104 FDA Bioterrorism; Establishment & Maintenance of Records FDA-2002-N-0153 Notice; public meeting on final rule. Notice NM-Notice of Meeting 2004-12-23T05:00:00Z 2004 12 2004-12-06T05:00:00Z   2009-08-18T14:10:53Z   0 0 09000064804933ed
FDA-2002-N-0153-0105 FDA Bioterrorism; Establishment & Maintenance of Records FDA-2002-N-0153 Final Rule - Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (pp 1-100) Notice NFR-Notice of Final Rule 2004-12-23T05:00:00Z 2004 12 2004-12-06T05:00:00Z   2009-08-18T14:21:36Z   0 0 09000064804933f0
FDA-2002-N-0153-0106 FDA Bioterrorism; Establishment & Maintenance of Records FDA-2002-N-0153 Final Rule - Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (pp 201-300) Notice NFR-Notice of Final Rule 2004-12-23T05:00:00Z 2004 12 2004-12-06T05:00:00Z   2009-08-18T14:25:30Z   0 0 09000064804933f3
FDA-2004-G-0002-0002 FDA Draft Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 FDA-2004-G-0002 Draft Guidance for Industry and FDA Staff; Draft Guidance for Records, Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 Supporting & Related Material Guidance 2004-12-23T05:00:00Z 2004 12     2025-11-13T21:09:57Z   0 0 090000648046a718
FDA-2004-M-0325-0001 FDA P040008 - VIDAS TPSA assay, Approved 7/8/04 FDA-2004-M-0325 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-08-01T21:25:35Z 04-27387 0 0 09000064804730d8
FDA-2004-M-0071-0001 FDA P970043/S015- LADARVision 4000 Excimer Laser System, Approved 6/29/04 FDA-2004-M-0071 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-07-29T23:29:00Z 04-27387 0 0 090000648046ecfe
FDA-2004-M-0138-0001 FDA P030054 - St. Jude Medical Epic HF System, Approved 6/30/04 FDA-2004-M-0138 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Application Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-07-30T00:17:04Z 04-27387 0 0 090000648046fde8
FDA-2004-M-0516-0001 FDA P030044 - DakoCytomation EGFR pharmDx, Approved 2/12/04 FDA-2004-M-0516 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Application Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-08-05T23:47:06Z 04-27387 0 0 0900006480477cb7
FDA-2004-M-0512-0001 FDA P020023 - Restylane Injectable Gel FDA-2004-M-0512 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applicatio Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-07-29T22:10:36Z 04-27387 0 0 0900006480477c56
FDA-2004-M-0196-0001 FDA P020030 - Stelid II steroid eluting pacing leads, Approved 6/17/04 FDA-2004-M-0196 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-07-29T22:58:57Z 04-27387 0 0 0900006480470b87
FDA-2004-M-0075-0001 FDA Premarket Approval for ImageChecker CT CAD Software System - Model LN-1000 by R2 Technology, Inc., Approved 7/8/04 (P030012) FDA-2004-M-0075 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-08-01T17:53:40Z 04-27387 0 0 090000648046ed44
FDA-2004-M-0563-0001 FDA Premarket Approval for CureLight BroadBand by PhotoCure ASA (Model CureLight 01), P010061, Approved 7/28/04 FDA-2004-M-0563 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-08-01T22:08:53Z 04-27387 0 0 09000064804815c2
FDA-2004-G-0002-0001 FDA Draft Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 FDA-2004-G-0002 Draft Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Availability Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-09T05:00:00Z 2005-01-25T04:59:59Z 2025-11-14T10:00:23Z 04-26931 0 0 090000648046a701
FDA-2003-F-0457-0001 FDA Increase the Maximum Permitted Energy Level of X-rays FDA-2003-F-0457 FDA Notice NFR-Notice of Final Rule 2004-12-23T05:00:00Z 2004 12 2004-12-22T05:00:00Z   2008-04-12T00:57:04Z   0 0 09000064804a26a0
FDA-2004-D-0122-0001 FDA Guidance for Small Business Entities on Labeling Over-the-Counter Human Drug Products; Availability FDA-2004-D-0122 Draft Compliance Guidance for Small Business Entities on Labeling Over-the-Counter Human Drug Products; Availability Notice NAD-Notice of Availability of Data 2004-12-23T05:00:00Z 2004 12 2004-12-08T05:00:00Z 2005-02-08T04:59:59Z 2009-05-11T15:38:00Z   0 0 090000648046fbbc
FDA-2004-D-0122-0004 FDA Guidance for Small Business Entities on Labeling Over-the-Counter Human Drug Products; Availability FDA-2004-D-0122 See FDA-2004-D-0122-0002 Supporting & Related Material GDL-Guidance 2004-12-23T05:00:00Z 2004 12     2009-05-11T15:46:51Z   0 0 090000648046fbc2
FDA-2002-N-0153-0108 FDA Bioterrorism; Establishment & Maintenance of Records FDA-2002-N-0153 Final Rule - Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (pp 101-200) Notice NFR-Notice of Final Rule 2004-12-23T05:00:00Z 2004 12 2004-12-06T05:00:00Z   2009-08-18T14:28:56Z   0 0 09000064804933f9
FDA-2004-M-0393-0001 FDA P030024 - Vitros Immunodiagnostic Products Anti-HBc Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc Calibrator, Approved 3/4/04 FDA-2004-M-0393 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-08-01T18:58:41Z 04-27387 0 0 0900006480474397
FDA-2004-M-0515-0001 FDA P030026 - Vitros Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc IgM Calibrator FDA-2004-M-0515 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applicatio11 Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-08-04T20:22:21Z 04-27387 0 0 0900006480477c92
FDA-2004-M-0078-0001 FDA P030025 - TAXUS Express2 Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire), Approved 3/4/04 FDA-2004-M-0078 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-08-05T00:10:21Z 04-27387 0 0 090000648046ed79
FDA-2002-N-0153-0107 FDA Bioterrorism; Establishment & Maintenance of Records FDA-2002-N-0153 Final Rule - Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (pp 301-344) Notice NFR-Notice of Final Rule 2004-12-23T05:00:00Z 2004 12 2004-12-06T05:00:00Z   2009-08-18T14:32:34Z   0 0 09000064804933f6
FDA-2003-M-0456-0001 FDA PMA Cypher Sirolimus-Eluting Coronary Stent on the Raptor FDA-2003-M-0456 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Approval 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-04-14T14:01:44Z   0 0 09000064804a2682
FDA-2004-P-0084-0001 FDA Cottage Cheese Deviating from Identity Standard; Temporary Permit for Market Testing FDA-2004-P-0084 Notice of Temporary Permit Notice N-Notice 2004-12-23T05:00:00Z 2004 12 2004-12-08T05:00:00Z 2004-12-10T04:59:59Z 2025-03-21T21:54:45Z 69FR71418 0 0 090000648046ee04
FDA-2004-M-0077-0001 FDA P040012 - ACCULINK Carotid Stent System and RX ACCULIN Carotid Stent System, Approved 8/30/04 FDA-2004-M-0077 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-08-04T22:26:11Z 04-27387 0 0 090000648046ed6a
FDA-2004-M-0197-0001 FDA P030010 - Siemens Mammomat Novation Full Field Digital Mammography System, Approved 8/20/04 FDA-2004-M-0197 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-08-04T21:55:14Z 04-27387 0 0 0900006480470b95
FDA-2004-M-0198-0001 FDA H030009 - Vertical Expandable Prosthetic Titanium Rib (VEPTR), approved August 24, 2004 FDA-2004-M-0198 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-08-05T21:14:54Z 04-27387 0 0 0900006480470ba2
FDA-2004-M-0140-0001 FDA P010012/S026 - CONTAK CD (Model 1823), CONTAK CD 2 (Models H115 and H119), RENEWAL (Model H135), RENEWAL 3 (Models H170, H175, H177, and H179), Approved 9/14/04 FDA-2004-M-0140 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Application Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-08-05T22:33:49Z 04-27387 0 0 090000648046fe0c
FDA-2004-P-0338-0001 FDA Refrain From Approving Any ANDA Submitted Under Section 505(j) of the FDCA for A Generic Version of Efudex Cream-CLOSED FDA-2004-P-0338 HFA-305 to Valeant Pharmaceuticals International Other ACK-Acknowledgement Letter 2004-12-22T05:00:00Z 2004 12     2008-04-12T00:49:25Z   0 0 09000064804732f6
FDA-2004-P-0338-0002 FDA Refrain From Approving Any ANDA Submitted Under Section 505(j) of the FDCA for A Generic Version of Efudex Cream-CLOSED FDA-2004-P-0338 HFA-305 to Valeant Pharmaceuticals International Other ACK-Acknowledgement Letter 2004-12-22T05:00:00Z 2004 12     2008-04-12T00:49:25Z   0 0 09000064804732ff
FDA-2004-S-0442-0003 FDA Solicitation of Comments on Stimulating Innovation in Medical Technologies FDA-2004-S-0442 Agenda for November 8, 2004 meeting Other LST-List 2004-12-21T05:00:00Z 2004 12     2008-04-12T00:52:54Z   0 0 0900006480474a96
FDA-2004-V-0030-0002 FDA Acuity, K033339 and On Board Imaging, K042720 Optional Therapy Simulation Systems FDA-2004-V-0030 HFA-305 to Varian Medical Systems Other ACK-Acknowledgement Letter 2004-12-21T05:00:00Z 2004 12     2008-04-12T00:52:58Z   0 0 090000648046a954
FDA-2004-D-0247-0002 FDA Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information FDA-2004-D-0247 GUIDANCE Supporting & Related Material GDL-Guidance 2004-12-21T05:00:00Z 2004 12     2008-04-12T00:35:26Z   0 0 0900006480471afc
FDA-2004-S-0442-0006 FDA Solicitation of Comments on Stimulating Innovation in Medical Technologies FDA-2004-S-0442 Attendees to November 8, 2004 meeting Other LST-List 2004-12-21T05:00:00Z 2004 12     2008-04-12T00:52:54Z   0 0 0900006480474a99
FDA-2004-N-0311-0001 FDA Agency Information Collection Activities: Proposed Collection; Comment Request; Experimental Study of Health Claims on Food Packages FDA-2004-N-0311 Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Health Claims on Food Packages Notice 60 Day Proposed Information Collection 2004-12-21T05:00:00Z 2004 12 2004-12-10T05:00:00Z 2005-02-09T04:59:59Z 2025-06-04T23:03:14Z 04-27119 0 0 0900006480472f08
FDA-1993-F-0015-0004 FDA Safe use of Source of Fast (high energy) Neutrons FDA-1993-F-0015 Reference 1 Findlay, Forrest and Smith Neutron-induced activation of food re: Irradiation in the Production, Processing and Handling of Food; Final Rule Supporting & Related Material Background Material 2004-12-21T05:00:00Z 2004 12     2016-02-16T18:08:05Z   0 0 09000064804fa571
FDA-1993-F-0015-0005 FDA Safe use of Source of Fast (high energy) Neutrons FDA-1993-F-0015 Reference 3 Easterly et al Assessment of Petition to Use Pulsed Fast Neutron Analysis (PFNA) in Inspection of Shipping Containers Containing Foods re: Irradiation in the Production, Processing and Handling of Food; Final Rule Supporting & Related Material Background Material 2004-12-21T05:00:00Z 2004 12     2016-02-16T18:17:12Z   0 0 09000064804fa572
FDA-2004-V-0362-0002 FDA Laser Light Show regarding Mobolazer RG-50 Beam FDA-2004-V-0362 HFA-305 to G and G Sound and Lighting Other ACK-Acknowledgement Letter 2004-12-21T05:00:00Z 2004 12     2008-04-12T00:53:37Z   0 0 0900006480473647
FDA-2004-N-0435-0001 FDA Medical Devices; General Hospital and Personal Use Devices; Classification of Implantable Radiofrequency Transponder System for Patient Identification and Health Information FDA-2004-N-0435 Medical Devices; General Hospital and Personal Use Devices; Classification of Implantable Radiofrequency Transponder System for Patient Identification and Health Information Notice Notice of Final Rule 2004-12-21T05:00:00Z 2004 12     2025-09-26T23:21:09Z 04-27077 0 0 090000648047496c
FDA-1993-F-0015-0001 FDA Safe use of Source of Fast (high energy) Neutrons FDA-1993-F-0015 Irradiation in the Production, Processing, and Handling of Food; Final rule Notice Notice of Final Rule 2004-12-21T05:00:00Z 2004 12 2004-12-21T05:00:00Z 2005-01-22T04:59:59Z 2016-02-16T22:00:55Z   0 0 09000064804fa56b
FDA-2004-S-0442-0004 FDA Solicitation of Comments on Stimulating Innovation in Medical Technologies FDA-2004-S-0442 Agenda for November 8, 2004 meeting Other LST-List 2004-12-21T05:00:00Z 2004 12     2008-04-12T00:52:55Z   0 0 0900006480474a97
FDA-2004-D-0247-0003 FDA Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information FDA-2004-D-0247 GUIDANCE Supporting & Related Material GDL-Guidance 2004-12-21T05:00:00Z 2004 12     2008-04-12T00:35:26Z   0 0 0900006480471afd
FDA-2004-V-0030-0001 FDA Acuity, K033339 and On Board Imaging, K042720 Optional Therapy Simulation Systems FDA-2004-V-0030 HFA-305 to Varian Medical Systems Other ACK-Acknowledgement Letter 2004-12-21T05:00:00Z 2004 12     2008-04-12T00:52:58Z   0 0 090000648046a950

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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);