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

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3,095 rows where agency_id = "FDA" and posted_year = 2007 sorted by posted_date descending

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  • 2007 · 3,095 ✖

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  • FDA · 3,095 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2007-P-0188-0001 FDA FDA-2007-P-0188 Acknowledgement Letter from FDA DDM to Beckloff Associates, Inc. Other Acknowledgement Letter/Receipt 2007-12-28T05:00:00Z 2007 12     2015-05-07T18:08:20Z   0 0 090000648042a763
FDA-2006-N-0364-0001 FDA Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile FDA-2006-N-0364 See FDA-2006-N-0364-0003 Supporting & Related Material BKG-Background Material 2007-12-28T05:00:00Z 2007 12     2008-06-18T17:26:35Z   0 0 090000648045fc49
FDA-2007-P-0178-0001 FDA FDA-2007-P-0178 See FDA-2007-P-0178-0002 Supporting & Related Material ACK-Acknowledgement Letter (Supporting and Related Material) 2007-12-28T05:00:00Z 2007 12     2008-05-16T19:41:33Z   0 0 090000648042a664
FDA-2007-D-0257-0001 FDA FDA-2007-D-0257 See Document ID FDA-2007-D-0257-0003 Notice   2007-12-28T00:00:00Z 2007 12     2008-05-21T20:22:03Z   0 1 090000648042b1c1
FDA-2007-D-0257-0002 FDA FDA-2007-D-0257 See Document ID FDA-2007-D-0257-0004 Other   2007-12-28T00:00:00Z 2007 12     2008-05-21T20:21:19Z   0 1 090000648042b1c4
FDA-2007-P-0414-0005 FDA FDA-2007-P-0414 Minutes of Telecon Between FDA/CDER and Dr. Victor Yu and Cristina Chiou Other MT-Memorandum of Telephone Conversation 2007-12-27T05:00:00Z 2007 12     2008-04-04T00:38:15Z   0 0 090000648042da1a
FDA-2007-N-0313-0001 FDA FDA-2007-N-0313 Maximizing the Public Health Benefit of Adverse Event Collection Throughout a Product's Marketed Life Cycle; Public Workshop; Request for Comments Notice NM-Notice of Meeting 2007-12-26T05:00:00Z 2007 12 2007-12-21T05:00:00Z 2008-03-01T04:59:59Z 2008-08-15T01:38:12Z   0 0 090000648042b70a
FDA-2007-N-0445-0003 FDA FDA-2007-N-0445 Number not used Other   2007-12-26T05:00:00Z 2007 12     2025-08-14T22:07:10Z   0 1 090000648042ddf6
FDA-2007-N-0197-0002 FDA FDA-2007-N-0197 Agenda - Adolescent Over-the-Counter (OTC) Drug Product Use: A Public Workshop Other LST-List 2007-12-26T05:00:00Z 2007 12     2025-08-14T20:30:52Z   0 0 090000648042a934
FDA-2007-N-0445-0002 FDA FDA-2007-N-0445 Number Not Used Other   2007-12-26T05:00:00Z 2007 12     2025-08-14T22:05:39Z   0 1 090000648042ddf5
FDA-2007-N-0445-0004 FDA FDA-2007-N-0445 Number not used Other   2007-12-26T05:00:00Z 2007 12     2025-08-14T22:08:41Z   0 1 090000648042ddf7
FDA-2007-N-0441-0001 FDA FDA-2007-N-0441 Agency Emergency Processing Under the Office of Management and Budget Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions; Correction Notice Correction 2007-12-26T05:00:00Z 2007 12     2025-08-19T20:11:21Z E7-24914 0 0 090000648042dda7
FDA-2007-C-0044-0001 FDA FDA-2007-C-0044 DSM Nutritional Products, Inc.; Filing of Color Additive Petition; Correction Notice NCR-Notice of Correction 2007-12-26T05:00:00Z 2007 12 2007-12-21T05:00:00Z   2026-01-08T20:18:17Z   0 0 0900006480429648
FDA-2007-N-0438-0002 FDA FDA-2007-N-0438 Acknowledgment Letter from FDA DDM to Buchanan Ingersoll & Rooney PC Other Acknowledgement Letter/Receipt 2007-12-26T05:00:00Z 2007 12     2025-08-11T20:21:37Z   0 0 090000648042dd74
FDA-2007-N-0152-0001 FDA FDA-2007-N-0152 Health Claims and Qualified Health Claims; Dietary Lipids and Cancer, Soy Protein and Coronary Heart Disease, Antioxidant Vitamins and Certain Cancers, and Selenium and Certain Cancers; Reevaluation; Opportunity for Public Comment Notice N-Notice 2007-12-21T05:00:00Z 2007 12 2007-12-21T05:00:00Z 2008-02-20T04:59:59Z 2008-07-08T18:53:47Z   0 0 090000648042a409
FDA-2006-V-0402-0005 FDA FDA-2006-V-0402 Lynne L. Rice Other VRA-Approval for Variance 2007-12-21T05:00:00Z 2007 12     2008-04-11T23:22:39Z   0 0 0900006480460c6c
FDA-2007-P-0235-0001 FDA FDA-2007-P-0235 Acknowledgment Letter from FDA CDER to Mutual Pharmaceutical Company, Inc. Other Acknowledgement Letter/Receipt 2007-12-21T05:00:00Z 2007 12     2015-09-29T13:12:16Z   0 0 090000648042b04d
FDA-2007-V-0252-0001 FDA FDA-2007-V-0252 Acknowledgement Letter to KRJ Music Work Other ACK-Acknowledgement Letter 2007-12-21T05:00:00Z 2007 12     2008-04-09T14:15:14Z   0 0 090000648042b160
FDA-2007-V-0356-0003 FDA FDA-2007-V-0356 Lynne L. Rice - Approval for Variance Other VRA-Approval for Variance 2007-12-20T05:00:00Z 2007 12     2008-04-09T16:14:25Z   0 0 090000648042ba0b
FDA-2007-A-0099-0002 FDA FDA-2007-A-0099 Letter from FDA CDER Interim Response to AstraZeneca Ropes and Gray LLP Other Letter(s) 2007-12-20T05:00:00Z 2007 12     2014-01-21T00:25:14Z   0 0 0900006480429d7a
FDA-2007-V-0426-0002 FDA FDA-2007-V-0426 Lynne L. Rice - Approval for Variance Other VRA-Approval for Variance 2007-12-20T05:00:00Z 2007 12     2008-04-09T18:31:27Z   0 0 090000648042dbe4
FDA-2007-P-0243-0001 FDA FDA-2007-P-0243 Acknowledgement Letter to Michael J. Dochniak Other ACK-Acknowledgement Letter 2007-12-20T05:00:00Z 2007 12     2008-07-22T22:56:16Z   0 0 090000648042b0be
FDA-2007-N-0083-0020 FDA FDA-2007-N-0083 Behind the Counter Availability of Certain Drugs; Public Meeting Wednesday, November 14, 2007 - Transcript Supporting & Related Material TR-Transcript 2007-12-19T05:00:00Z 2007 12     2008-05-12T06:10:30Z   0 0 0900006480429b07
FDA-2007-M-0452-0001 FDA FDA-2007-M-0452 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Approval 2007-12-19T05:00:00Z 2007 12 2007-12-19T05:00:00Z   2026-01-09T22:48:41Z E7-24620 0 0 090000648042dec7
FDA-2007-N-0083-0021 FDA FDA-2007-N-0083 Behind the Counter Availability of Certain Drugs; Press Briefing on Public Meeting Wednesday, November 14, 2007 - Transcript Supporting & Related Material TR-Transcript 2007-12-19T05:00:00Z 2007 12     2008-05-12T06:12:01Z   0 0 0900006480429b08
FDA-2007-M-0273-0001 FDA FDA-2007-M-0273 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Approval 2007-12-19T05:00:00Z 2007 12 2007-12-19T05:00:00Z   2026-01-09T21:15:57Z E7-24620 0 0 090000648042b3c6
FDA-2007-M-0453-0001 FDA FDA-2007-M-0453 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Approval 2007-12-19T05:00:00Z 2007 12 2007-12-19T05:00:00Z   2026-01-10T00:23:52Z E7-24620 0 0 090000648042ded7
FDA-2007-M-0325-0001 FDA FDA-2007-M-0325 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Approval 2007-12-19T05:00:00Z 2007 12 2007-12-19T05:00:00Z   2026-01-10T04:01:42Z E7-24620 0 0 090000648042b804
FDA-2007-N-0382-0001 FDA FDA-2007-N-0382 Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting Notice Meeting 2007-12-19T05:00:00Z 2007 12     2025-08-19T15:55:54Z E7-24629 0 0 090000648042d70f
FDA-2007-M-0397-0001 FDA FDA-2007-M-0397 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Approval 2007-12-19T05:00:00Z 2007 12 2007-12-19T05:00:00Z   2026-01-12T23:22:10Z E7-24620 0 0 090000648042d84e
FDA-2007-M-0224-0001 FDA FDA-2007-M-0224 FDA Notice NAL-Notice of Approval 2007-12-19T05:00:00Z 2007 12 2007-12-19T05:00:00Z   2008-04-04T00:35:16Z   0 0 090000648042ae2e
FDA-2007-M-0223-0001 FDA FDA-2007-M-0223 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Approval 2007-12-19T05:00:00Z 2007 12 2007-12-19T05:00:00Z   2026-01-09T23:33:10Z E7-24620 0 0 090000648042ae1d
FDA-2007-M-0093-0001 FDA FDA-2007-M-0093 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Approval 2007-12-19T05:00:00Z 2007 12 2007-12-19T05:00:00Z   2026-01-13T00:37:18Z E7-24620 0 0 0900006480429d20
FDA-2005-D-0013-0007 FDA Collection of Platelets by Automated Methods FDA-2005-D-0013 Collection of Platelets by Automated Methods Supporting & Related Material Guidance 2007-12-18T05:00:00Z 2007 12     2020-05-14T14:55:21Z   0 0 090000648043e53e
FDA-2007-D-0306-0002 FDA FDA-2007-D-0306 International Conference on Harmonisation; Draft Guidance on Q4B Notice NAD-Notice of Availability of Data 2007-12-18T05:00:00Z 2007 12 2007-12-14T05:00:00Z 2008-02-16T04:59:59Z 2009-01-12T16:01:41Z   0 0 090000648042b66c
FDA-2007-D-0200-0002 FDA FDA-2007-D-0200 International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex on Test for Extractable Volume of Parenteral Preparations General Chapter; Availibilty Notice NAD-Notice of Availability of Data 2007-12-18T05:00:00Z 2007 12 2007-12-14T05:00:00Z 2008-02-16T04:59:59Z 2008-05-28T19:58:35Z   0 0 090000648042abc7
FDA-2007-D-0306-0001 FDA FDA-2007-D-0306 4QB Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions, Annex 3 - Guidance - Draft Guidance Supporting & Related Material GDL-Guidance 2007-12-18T05:00:00Z 2007 12     2009-01-12T16:04:33Z   0 0 090000648042b66d
FDA-2007-D-0200-0001 FDA FDA-2007-D-0200 See FDA-2007-D-0200-0003 Supporting & Related Material GDL-Guidance 2007-12-18T05:00:00Z 2007 12     2010-04-07T15:41:46Z   0 0 090000648042abc9
FDA-2005-D-0013-0008 FDA Collection of Platelets by Automated Methods FDA-2005-D-0013 FDA Notice NAD-Notice of Availability of Data 2007-12-18T05:00:00Z 2007 12 2007-12-14T05:00:00Z 2008-12-16T04:59:59Z 2008-04-11T23:46:16Z   0 0 090000648043e53f
FDA-2007-P-0184-0001 FDA FDA-2007-P-0184 Acknowledgement Letter to Judy Slome Cohain Other ACK-Acknowledgement Letter 2007-12-18T05:00:00Z 2007 12     2008-07-07T17:57:57Z   0 0 090000648042a728
FDA-2007-P-0110-0001 FDA FDA-2007-P-0110 FDA/DDM to Physicians Committee for Responsible Medicine (PCRM) Other ACK-Acknowledgement Letter 2007-12-18T05:00:00Z 2007 12     2008-04-04T00:37:11Z   0 0 0900006480429e5f
FDA-2006-P-0275-0006 FDA Refrain from Approval of Any Abbreviated New Drug Application (ANDA) for Metoprolol Succinate Extended Release100 mg & 200 mg Tablets Subsequent to ANDA 76-640 from K. V. Pharmaceuticals-CLOSED FDA-2006-P-0275 Citizen Petition Denial from FDA CDER to KV Pharmaceutical Co Other Denial of Petition 2007-12-17T05:00:00Z 2007 12     2024-12-05T14:53:49Z   0 0 090000648045829b
FDA-2007-P-0417-0001 FDA FDA-2007-P-0417 Acknowledgement Letter to Consumers Union Other ACK-Acknowledgement Letter 2007-12-17T05:00:00Z 2007 12     2013-05-15T19:58:29Z   0 0 090000648042da4d
FDA-2007-N-0319-0001 FDA FDA-2007-N-0319 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Health and Diet Survey Notice 30 Day Proposed Information Collection 2007-12-17T05:00:00Z 2007 12 2007-12-13T05:00:00Z 2008-01-15T04:59:59Z 2025-07-18T17:30:47Z E7-24123 0 0 090000648042b7c7
FDA-2007-P-0122-0052 FDA FDA-2007-P-0122 FDA/CFSAN Interim Response to Compassion Over Killing & Penn Law Animal Law Project-University of Pennsylvania Law School - Letter Other LET-Letter 2007-12-17T05:00:00Z 2007 12     2008-11-26T05:47:43Z   0 0 090000648042a1cf
FDA-2005-P-0253-0019 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442e7
FDA-2005-P-0253-0006 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442da
FDA-2005-P-0253-0005 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442d9
FDA-2005-P-0253-0013 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442e1
FDA-2005-P-0253-0012 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442e0
FDA-2005-P-0253-0021 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442e9
FDA-2005-P-0253-0008 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442dc
FDA-2005-P-0253-0016 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442e4
FDA-2005-P-0253-0009 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:03Z   0 0 09000064804442dd
FDA-2005-P-0253-0010 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442de
FDA-2005-P-0253-0017 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442e5
FDA-2005-P-0253-0014 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442e2
FDA-2005-P-0253-0015 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442e3
FDA-2005-P-0253-0018 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442e6
FDA-2005-P-0253-0020 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442e8
FDA-2005-P-0253-0011 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:03Z   0 0 09000064804442df
FDA-2005-P-0253-0007 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442db
FDA-2005-P-0253-0022 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442ea
FDA-2007-V-0421-0001 FDA FDA-2007-V-0421 Acknowledgement Letter to X- Laser L. L. C. Other ACK-Acknowledgement Letter 2007-12-12T05:00:00Z 2007 12     2008-04-09T18:12:29Z   0 0 090000648042daca
FDA-2007-V-0253-0001 FDA FDA-2007-V-0253 Acknowledgement Letter to X- Laser, L. L. C. Other ACK-Acknowledgement Letter 2007-12-12T05:00:00Z 2007 12     2008-04-09T14:30:16Z   0 0 090000648042b16e
FDA-2007-N-0441-0002 FDA FDA-2007-N-0441 Agency Emergency Processing Under the Office of Management and Budget Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions Notice General Notice 2007-12-12T05:00:00Z 2007 12 2007-12-12T05:00:00Z 2007-12-18T04:59:59Z 2025-08-19T20:24:09Z 07-6023 0 0 090000648042dda4
FDA-2007-N-0272-0002 FDA FDA-2007-N-0272 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Presubmission Conferences, New Animal Drug Applications and Supporting Regulations and Guidance 152, and Form FDA 356V Notice 30 Day Proposed Information Collection 2007-12-11T05:00:00Z 2007 12 2007-12-11T05:00:00Z 2008-01-11T04:59:59Z 2025-07-23T19:31:13Z E7-23998 0 0 090000648042b3bd
FDA-2007-N-0220-0002 FDA FDA-2007-N-0220 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Pharmacogenomic Data Submissions; Extension Notice 30 Day Proposed Information Collection 2007-12-11T05:00:00Z 2007 12 2007-12-11T05:00:00Z 2008-01-11T04:59:59Z 2025-08-07T22:57:55Z E7-23996 0 0 090000648042adfb
FDA-2007-N-0383-0003 FDA FDA-2007-N-0383 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees Notice 30 Day Proposed Information Collection 2007-12-11T05:00:00Z 2007 12 2007-12-10T05:00:00Z 2008-01-11T04:59:59Z 2025-08-11T16:06:25Z E7-23977 0 0 090000648042d750
FDA-2000-P-0152-0011 FDA Amend Part 133.3 Re: Milk & Nonfat Milk for Use in Standardization FDA-2000-P-0152 Background Material Supporting & Related Material BKG-Background Material 2007-12-11T05:00:00Z 2007 12     2008-04-25T01:44:23Z   0 0 09000064804d1372
FDA-2007-C-0044-0002 FDA FDA-2007-C-0044 DSM Nutritional Products, Inc.; Filing of Color Additive Petition Notice NFL-Notice of Filing 2007-12-11T05:00:00Z 2007 12 2007-12-03T05:00:00Z   2026-01-08T20:19:27Z   0 0 0900006480429647
FDA-2000-P-0152-0015 FDA Amend Part 133.3 Re: Milk & Nonfat Milk for Use in Standardization FDA-2000-P-0152 Background Material Supporting & Related Material BKG-Background Material 2007-12-11T05:00:00Z 2007 12     2008-04-25T01:44:24Z   0 0 09000064804d1378
FDA-2007-P-0288-0002 FDA FDA-2007-P-0288 FDA/CDRH to Clinical and Laboratory Standards Institute Other LET-Letter 2007-12-11T05:00:00Z 2007 12     2008-04-04T00:37:52Z   0 0 090000648042b4f1
FDA-2007-P-0187-0001 FDA FDA-2007-P-0187 FDA/DDM to Alston & Bird LLP Other ACK-Acknowledgement Letter 2007-12-11T05:00:00Z 2007 12     2008-04-04T00:37:35Z   0 0 090000648042a754
FDA-2007-N-0080-0001 FDA FDA-2007-N-0080 Establishment of Fiscal Year 2008 User Fee Rates for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biological Products Notice General Notice 2007-12-11T05:00:00Z 2007 12     2025-08-19T00:31:05Z E7-24000 0 0 09000064804298e2
FDA-2007-P-0115-0002 FDA FDA-2007-P-0115 CDRH to Clinical and Laboratory Standards Institute Other LET-Letter 2007-12-11T05:00:00Z 2007 12     2008-04-04T00:37:13Z   0 0 0900006480429ef7
FDA-2000-P-0152-0014 FDA Amend Part 133.3 Re: Milk & Nonfat Milk for Use in Standardization FDA-2000-P-0152 Background Material Supporting & Related Material BKG-Background Material 2007-12-11T05:00:00Z 2007 12     2008-04-25T01:44:21Z   0 0 09000064804d1376
FDA-2000-P-0152-0013 FDA Amend Part 133.3 Re: Milk & Nonfat Milk for Use in Standardization FDA-2000-P-0152 Background Material Supporting & Related Material BKG-Background Material 2007-12-11T05:00:00Z 2007 12     2008-04-25T01:44:18Z   0 0 09000064804d1375
FDA-2007-P-0187-0002 FDA FDA-2007-P-0187 FDA/DDM to Alston & Bird LLP Other ACK-Acknowledgement Letter 2007-12-11T05:00:00Z 2007 12     2008-04-04T00:37:35Z   0 0 090000648042a759
FDA-2007-N-0266-0001 FDA FDA-2007-N-0266 Agency Information Collection Activities; Proposed Collection; Comment Request; Reports of Corrections and Removals Notice N-Notice 2007-12-11T05:00:00Z 2007 12 2007-12-11T05:00:00Z 2008-02-12T04:59:59Z 2025-08-18T23:08:07Z E7-23962 0 0 090000648042b37a
FDA-2000-P-0152-0010 FDA Amend Part 133.3 Re: Milk & Nonfat Milk for Use in Standardization FDA-2000-P-0152 FDA Notice NEC-Notice of Extension 2007-12-11T05:00:00Z 2007 12 2007-12-10T05:00:00Z 2008-02-12T04:59:59Z 2008-04-25T01:44:24Z   0 0 09000064804d1371
FDA-2000-P-0152-0012 FDA Amend Part 133.3 Re: Milk & Nonfat Milk for Use in Standardization FDA-2000-P-0152 Background Material Supporting & Related Material BKG-Background Material 2007-12-11T05:00:00Z 2007 12     2008-04-25T01:44:21Z   0 0 09000064804d1373
FDA-2007-0629-0001 FDA FDA-2007-0629 Cheeses and Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk; Reopening of the Comment Period Proposed Rule NPR-Notice of Proposed Rule-Making 2007-12-11T05:00:00Z 2007 12 2007-12-11T05:00:00Z 2008-02-12T04:59:59Z 2008-02-11T12:07:54Z E7-23981 0 0 09000064803779cd
FDA-2000-P-0152-0016 FDA Amend Part 133.3 Re: Milk & Nonfat Milk for Use in Standardization FDA-2000-P-0152 Background Material Supporting & Related Material BKG-Background Material 2007-12-11T05:00:00Z 2007 12     2008-04-25T01:44:23Z   0 0 09000064804d137b
FDA-2007-N-0087-0001 FDA FDA-2007-N-0087 Agency Information Collection Activities; Proposed Collection; Comment Request; Mental Models Study of Communicating With Health Care Providers About the Risks and Benefits of Prescription Drug Use for Pregnant and Nursing Women With Chronic Conditions Notice 60 Day Proposed Information Collection 2007-12-11T05:00:00Z 2007 12 2007-12-10T05:00:00Z 2008-02-12T04:59:59Z 2025-09-24T22:10:20Z E7-23976 0 0 0900006480429c98
FDA-1978-N-0018-0629 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Envelope re: Comment from The Honorable Benjamin J. Lambert III, Senate of Virginia Supporting & Related Material Transmittals 2007-12-07T05:00:00Z 2007 12     2019-07-29T15:44:10Z   0 0 090000648055c0f1
FDA-1978-N-0018-0628 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Envelope re: Comment from The Honorable Benjamin J. Lambert III, Senate of Virginia Supporting & Related Material Transmittals 2007-12-07T05:00:00Z 2007 12     2019-07-29T15:47:20Z   0 0 090000648055c0ee
FDA-2007-P-0066-0001 FDA FDA-2007-P-0066 FDA/ DDM to William L. Driscoll Other ACK-Acknowledgement Letter 2007-12-07T05:00:00Z 2007 12     2008-04-04T00:37:08Z   0 0 09000064804297f2
FDA-2007-E-0281-0005 FDA FDA-2007-E-0281 FDA/CDER to the USPTO - Letter Other LET-Letter 2007-12-06T05:00:00Z 2007 12     2026-01-06T23:23:28Z   0 0 090000648042b44b
FDA-2007-P-0245-0003 FDA FDA-2007-P-0245 FDA/CDER Interim Response to Perdue Pharma L.P. - Letter Other LET-Letter 2007-12-06T05:00:00Z 2007 12     2009-03-28T18:18:01Z   0 0 090000648042b0f0
FDA-2006-N-0239-0007 FDA Index of Legally Marketed Unapproved New Animal Drugs for Minor Species FDA-2006-N-0239 Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Final Rule Notice Notice of Final Rule 2007-12-06T05:00:00Z 2007 12 2007-12-05T05:00:00Z   2015-12-15T17:50:54Z   0 0 0900006480456f42
FDA-1978-N-0018-0626 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Envelope re: Comment from Harry R. (Bob) Purkey Supporting & Related Material Transmittals 2007-12-05T05:00:00Z 2007 12     2019-07-29T15:24:09Z   0 0 090000648055c0e4
FDA-2007-E-0106-0007 FDA FDA-2007-E-0106 USPTO to Intervet Inc. - Letter Other LET-Letter 2007-12-05T05:00:00Z 2007 12     2008-05-02T15:45:09Z   0 0 0900006480429e1e
FDA-2007-P-0234-0001 FDA FDA-2007-P-0234 Acknowledgement Letter to Terence J. Mix, Esq. Other ACK-Acknowledgement Letter 2007-12-04T05:00:00Z 2007 12     2012-09-22T20:26:02Z   0 0 090000648042b03f
FDA-2007-0614-0001 FDA FDA-2007-0614 Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Companion Document to the Direct Final Rule Proposed Rule Notice of Proposed Rulemaking (NPRM) 2007-12-04T05:00:00Z 2007 12 2007-12-04T05:00:00Z 2008-02-20T04:59:59Z 2015-12-07T15:03:20Z E7-23292 0 0 090000648036fb2c
FDA-2007-F-0330-0001 FDA FDA-2007-F-0330 General Mills, Inc.; Filing of Food Additive Petition (FAP 7M4770) Notice NFL-Notice of Filing 2007-12-04T05:00:00Z 2007 12 2007-11-30T05:00:00Z   2026-01-08T19:37:41Z   0 0 090000648042b848
FDA-2007-N-0074-0001 FDA FDA-2007-N-0074 Number not used Notice NFL-Notice of Filing 2007-12-04T05:00:00Z 2007 12 2007-12-03T05:00:00Z   2008-04-04T00:35:37Z   0 0 090000648042988b
FDA-2007-N-0379-0002 FDA FDA-2007-N-0379 Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals Rule Direct Final Rule 2007-12-04T05:00:00Z 2007 12 2007-12-04T05:00:00Z 2008-02-20T04:59:59Z 2025-07-28T22:38:38Z E7-23294 0 0 090000648042c911
FDA-2007-N-0379-0001 FDA FDA-2007-N-0379 Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Companion Document to the Direct Final Rule Proposed Rule Notice of Proposed Rulemaking (NPRM) 2007-12-04T05:00:00Z 2007 12 2007-12-04T05:00:00Z 2008-02-20T04:59:59Z 2025-07-29T09:00:10Z E7-23292 0 0 090000648042c910
FDA-2007-P-0182-0002 FDA FDA-2007-P-0182 FDA Center for Drug and Evaluation Research Response to Sanofi Aventis - Letter Other LET-Letter 2007-12-04T05:00:00Z 2007 12     2008-07-15T23:43:46Z   0 0 090000648042a706

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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);