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1,680 rows where document_type = "Other" and posted_year = 2007 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-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-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-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-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-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-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-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-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-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-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 | |||
| USDA-2007-0001-0002 | USDA | Semiannual Regulatory Agenda - Fall 2007 USDA-2007-0001 | Regulatory Plan - Fall 2007 | Other | NA | 2007-12-10T14:46:29Z | 2007 | 12 | 2007-12-10T16:47:08Z | 0 | 0 | 0900006480375b95 | |||
| USDA-2007-0001-0001 | USDA | Semiannual Regulatory Agenda - Fall 2007 USDA-2007-0001 | Semiannual Regulatory Agenda - Fall 2007 | Other | NA | 2007-12-10T14:46:14Z | 2007 | 12 | 2007-12-10T16:46:40Z | 0 | 0 | 0900006480375b94 | |||
| EPA-HQ-OA-2007-1172-0001 | EPA | Semiannual Regulatory Agenda - Fall 2007 EPA-HQ-OA-2007-1172 | Semiannual Regulatory Agenda - Fall 2007 | Other | Significant Guidance | 2007-12-10T14:42:07Z | 2007 | 12 | 2010-07-15T19:23:55Z | 0 | 0 | 0900006480375b20 | |||
| 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-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-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 | |||
| EPA-R09-OAR-2007-1103-0003 | EPA | EPA-R09-OAR-2007-1103 | Proposed Part 71 Permit for Salt River Landfill | Other | 2007-12-03T05:00:00Z | 2007 | 12 | 2007-12-03T05:00:00Z | 2008-01-08T04:59:59Z | 2008-01-08T21:22:03Z | 0 | 0 | 090000648036e43d | ||
| FDA-2007-H-0094-0003 | FDA | FDA-2007-H-0094 | FDA Division of Dockets Management - Certificate of Service [FDA-2007-H-0094-0018] | Other | CS-Certificate of Service | 2007-12-03T05:00:00Z | 2007 | 12 | 2026-01-06T23:41:59Z | 0 | 0 | 0900006480429d34 | |||
| FDA-2007-H-0094-0002 | FDA | FDA-2007-H-0094 | FDA/Administrative Law Judge - Order [FDA-2007-H-0094-0017] | Other | OR-Order | 2007-12-03T05:00:00Z | 2007 | 12 | 2026-01-06T23:40:08Z | 0 | 0 | 0900006480429d33 | |||
| FDA-2020-D-1925-0001 | FDA | FDA-2020-D-1925 | Guidance for Industry: Preparation of Premarket Submissions for Food Contact Substances (Chemistry Recommendations) | Other | Guidance | 2007-12-01T05:00:00Z | 2007 | 12 | 2020-09-17T04:00:00Z | 2024-11-12T23:24:55Z | 1 | 0 | 090000648486323c | ||
| EPA-R09-OAR-2007-0985-0012 | EPA | EPA-R09-OAR-2007-0985 | Cover Letter to Revised Proposed Permit | Other | 2007-11-30T05:00:00Z | 2007 | 11 | 2007-11-30T05:00:00Z | 2008-01-08T21:16:05Z | 0 | 0 | 090000648036b119 | |||
| EPA-R09-OAR-2007-0985-0014 | EPA | EPA-R09-OAR-2007-0985 | November 30, 2007 Revised Statement of Basis and Ambient Air Quality Impact Report | Other | 2007-11-30T05:00:00Z | 2007 | 11 | 2007-11-30T05:00:00Z | 2008-01-08T21:20:17Z | 0 | 0 | 090000648036b17f | |||
| FDA-2006-P-0006-0005 | FDA | To permit an ANDA Suitability for Eloxatin (Oxaliplatin for injection) FDA-2006-P-0006 | Letter from FDA CDER to AAC Consulting Group/Kendle | Other | Letter(s) | 2007-11-30T05:00:00Z | 2007 | 11 | 2024-11-14T14:39:25Z | 0 | 0 | 0900006480441445 | |||
| FDA-2007-P-0123-0001 | FDA | FDA-2007-P-0123 | Acknowledgement Letter to United Research Laboratories, Inc., Mutual Pharmaceutical Company, Inc. | Other | ACK-Acknowledgement Letter | 2007-11-30T05:00:00Z | 2007 | 11 | 2008-10-01T15:30:49Z | 0 | 0 | 090000648042a1d7 | |||
| FDA-2005-D-0445-0008 | FDA | Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle, re FDA-2012-N-0115 FDA-2005-D-0445 | Guidance for Industry and Food and Drug Administration Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle; Final Guidance Document | Other | Guidance | 2007-11-30T05:00:00Z | 2007 | 11 | 2015-01-21T00:13:53Z | 0 | 0 | 09000064804505f2 | |||
| FDA-2006-P-0069-0005 | FDA | ANDA for ELOXATIN (oxaliplatin for injection) lyophilized powder for infusion, 50 mg and 100 mg vials FDA-2006-P-0069 | Letter from FDA CDER to Frommer, Lawrence & Haug LLP | Other | Letter(s) | 2007-11-30T05:00:00Z | 2007 | 11 | 2024-11-13T14:54:20Z | 0 | 0 | 0900006480444465 | |||
| FDA-2007-P-0247-0006 | FDA | FDA-2007-P-0247 | Letter from FDA CDER to Regulus Pharmaceutical Consulting, Inc | Other | Letter(s) | 2007-11-30T05:00:00Z | 2007 | 11 | 2025-03-04T22:09:52Z | 0 | 0 | 090000648042b114 | |||
| FDA-2006-P-0201-0005 | FDA | Determine whether Eloxatin (Oxaliplatin for Injection) 50 mg and 100 mg sterile lyophilized powder vials (NDA #21-492 has been withdrawn for safety or effectiveness reasons FDA-2006-P-0201 | Elizabeth Sadove - FDA/CDER Final Response | Other | LET-Letter | 2007-11-30T05:00:00Z | 2007 | 11 | 2008-06-19T19:56:35Z | 0 | 0 | 0900006480450f53 | |||
| FDA-2006-P-0085-0005 | FDA | Determine whether Eloxatin (Oxaliplatin for Injection) has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons FDA-2006-P-0085 | Letter from FDA CDER to Sicor Pharmaceuticals, Inc. | Other | Letter(s) | 2007-11-30T05:00:00Z | 2007 | 11 | 2024-11-04T19:39:47Z | 0 | 0 | 090000648044498d | |||
| FDA-2007-P-0410-0001 | FDA | FDA-2007-P-0410 | FDA/DDM to Medicure Pharma, Inc. - Acknowledgement Letter | Other | ACK-Acknowledgement Letter | 2007-11-30T05:00:00Z | 2007 | 11 | 2009-03-31T13:27:52Z | 0 | 0 | 090000648042d9a6 | |||
| FDA-2005-D-0227-0019 | FDA | Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004; Guidance (Edition 2) FDA-2005-D-0227 | FDA/CFSAN Response to Olga Nichols - Answer | Other | Answer | 2007-11-29T05:00:00Z | 2007 | 11 | 2012-03-14T01:00:38Z | 0 | 0 | 09000064804420a7 | |||
| FDA-2007-P-0403-0003 | FDA | FDA-2007-P-0403 | Petition Approval from FDA CVM to Norbrook Inc | Other | Letter(s) | 2007-11-28T00:00:00Z | 2007 | 11 | 2025-05-09T00:32:49Z | 0 | 0 | 090000648042d905 | |||
| FDA-2005-D-0227-0018 | FDA | Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004; Guidance (Edition 2) FDA-2005-D-0227 | FDA/CFSAN Response to Taro Dream Inc. (Pamela Day) - Answer | Other | Answer | 2007-11-27T05:00:00Z | 2007 | 11 | 2012-03-14T00:52:52Z | 0 | 0 | 09000064804420a4 | |||
| FDA-2007-P-0005-0003 | FDA | FDA-2007-P-0005 | Interim Response Letter from FDA CDRH to Association of Medical Device Reprocessors | Other | Letter(s) | 2007-11-27T00:00:00Z | 2007 | 11 | 2025-05-08T19:39:46Z | 0 | 0 | 0900006480429280 | |||
| FDA-2007-P-0109-0001 | FDA | FDA-2007-P-0109 | Acknowledgement Letter to Mandatory Alternatives Petition Coalition | Other | ACK-Acknowledgement Letter | 2007-11-26T05:00:00Z | 2007 | 11 | 2008-05-09T21:44:06Z | 0 | 0 | 0900006480429e51 | |||
| FDA-2007-D-0132-0002 | FDA | FDA-2007-D-0132 | Guidance | Other | GDL-Guidance | 2007-11-23T05:00:00Z | 2007 | 11 | 2019-08-20T18:59:46Z | 0 | 0 | 090000648042a2b9 | |||
| FDA-2006-P-0205-0004 | FDA | Health Claim Petition: Barley Betafiber and Coronary Heart Disease FDA-2006-P-0205 | FDA/CFSAN Request to Dockets Management - Letter | Other | LET-Letter | 2007-11-23T05:00:00Z | 2007 | 11 | 2009-01-23T21:32:10Z | 0 | 0 | 090000648045139b | |||
| FDA-1999-D-0048-0007 | FDA | Impurities in New Veterinary Medicinal Products; International Cooperation on Harmonisation of Technical Requirements, VICH GL11 FDA-1999-D-0048 | Guidance for Industry Impurities in New Veterinary Medicinal Products (Revised) VICH GL11 (R) Revised Final Guidance | Other | Guidance | 2007-11-23T05:00:00Z | 2007 | 11 | 2025-06-10T18:44:15Z | 0 | 0 | 09000064804a600a | |||
| FDA-2007-E-0461-0002 | FDA | FDA-2007-E-0461 | FDA/CDER to U.S. Patent and Trademark Office | Other | LET-Letter | 2007-11-21T05:00:00Z | 2007 | 11 | 2008-04-04T00:35:05Z | 0 | 0 | 090000648042df85 | |||
| FDA-2007-E-0282-0002 | FDA | FDA-2007-E-0282 | FDA/CDER to USPTO - Letter | Other | LET-Letter | 2007-11-21T05:00:00Z | 2007 | 11 | 2008-12-05T18:44:49Z | 0 | 0 | 090000648042b460 | |||
| FDA-2006-D-0299-0005 | FDA | Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision) VICH GL3 (R) (#73) FDA-2006-D-0299 | CVM GFI #73 (VICH GL3(R)) Stability Testing of New Veterinary Drug Substances | Other | Guidance | 2007-11-21T05:00:00Z | 2007 | 11 | 2007-11-21T05:00:00Z | 2024-11-07T21:52:21Z | 1 | 0 | 0900006480458fb9 | ||
| FDA-2007-E-0165-0002 | FDA | FDA-2007-E-0165 | Letter from FDA/CDER to USPTO | Other | LET-Letter | 2007-11-21T05:00:00Z | 2007 | 11 | 2026-01-06T01:03:51Z | 0 | 0 | 090000648042a511 | |||
| EPA-HQ-OPP-2007-0725-0001 | EPA | EPA-HQ-OPP-2007-0725 | Special Docket: Acetochlor Registration Agreement and Monitoring Program | Other | NA | 2007-11-20T05:00:00Z | 2007 | 11 | 2007-11-20T05:00:00Z | 2009-05-18T12:11:58Z | 0 | 0 | 09000064803664e8 | ||
| FDA-2005-D-0227-0017 | FDA | Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004; Guidance (Edition 2) FDA-2005-D-0227 | FDA/CFSAN Response to Su Alai - Answer | Other | Answer | 2007-11-20T05:00:00Z | 2007 | 11 | 2012-03-14T00:44:08Z | 0 | 0 | 09000064804420a2 | |||
| FDA-2004-P-0338-0005 | 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 | Ted Sherwood | Other | MM-Memorandum of Meeting | 2007-11-20T05:00:00Z | 2007 | 11 | 2008-04-12T00:49:25Z | 0 | 0 | 0900006480473328 | |||
| FDA-2007-N-0198-0004 | FDA | FDA-2007-N-0198 | FDA/CFSAN/ONLDS | Other | M-Memorandum | 2007-11-20T05:00:00Z | 2007 | 11 | 2008-04-04T00:35:55Z | 0 | 0 | 090000648042a9d3 | |||
| FDA-2007-N-0198-0005 | FDA | FDA-2007-N-0198 | FDA/CFSAN/ONLDS | Other | TR-Transcript | 2007-11-20T05:00:00Z | 2007 | 11 | 2008-04-04T00:35:55Z | 0 | 0 | 090000648042a9d4 | |||
| FDA-2007-N-0198-0003 | FDA | FDA-2007-N-0198 | FDA/CFSAN/ONLDS | Other | M-Memorandum | 2007-11-20T05:00:00Z | 2007 | 11 | 2008-04-04T00:35:55Z | 0 | 0 | 090000648042a9d2 | |||
| FDA-2007-P-0416-0001 | FDA | FDA-2007-P-0416 | Acknowledgement Letter from FDA DDM to Sapna Lohiya (Royal Medical Group) | Other | Acknowledgement Letter/Receipt | 2007-11-20T05:00:00Z | 2007 | 11 | 2016-03-10T16:24:35Z | 0 | 0 | 090000648042da3a | |||
| FDA-2007-N-0198-0006 | FDA | FDA-2007-N-0198 | FDA/CFSAN/ONLDS | Other | TR-Transcript | 2007-11-20T05:00:00Z | 2007 | 11 | 2008-04-04T00:35:55Z | 0 | 0 | 090000648042a9d5 | |||
| FDA-2007-P-0064-0002 | FDA | FDA-2007-P-0064 | FDA/CDER to Center for Dermatology and Laser Surgery | Other | LET-Letter | 2007-11-20T05:00:00Z | 2007 | 11 | 2008-04-04T00:37:07Z | 0 | 0 | 09000064804297ca | |||
| FDA-2007-P-0051-0001 | FDA | FDA-2007-P-0051 | Acknowledgement Letter to Sidelines National Support Network | Other | ACK-Acknowledgement Letter | 2007-11-19T05:00:00Z | 2007 | 11 | 2008-04-11T19:55:24Z | 0 | 0 | 09000064804296d6 | |||
| FDA-2006-E-0383-0007 | FDA | Patent Extension Application for LEVEMIR insulin detemir (rDNA origin) injection, U.S. Patent No. 5,750,497 FDA-2006-E-0383 | Notice of Final Determination from U.S. Patent and Trademark Office to Novo Nordisk, A/S | Other | Letter(s) | 2007-11-19T05:00:00Z | 2007 | 11 | 2025-12-19T21:52:23Z | 0 | 0 | 09000064804603ab | |||
| FDA-2007-P-0352-0002 | FDA | FDA-2007-P-0352 | FDA/CDER Interim Response to Sheppard, Mullin, Richter & Hampton, LLP - Letter | Other | LET-Letter | 2007-11-19T05:00:00Z | 2007 | 11 | 2013-07-27T20:40:29Z | 0 | 0 | 090000648042b9da | |||
| FDA-2006-E-0261-0006 | FDA | Patent Extension Application for BARACLUDE (entecavir), U.S. Patent No. 5,206,244 FDA-2006-E-0261 | USPTO to Bristol-Myers Squibb Company - Notice of Final Determination | Other | LET-Letter | 2007-11-19T05:00:00Z | 2007 | 11 | 2008-05-28T16:43:42Z | 0 | 0 | 0900006480457a3a | |||
| FDA-2007-P-0246-0002 | FDA | FDA-2007-P-0246 | FDA/CDER tp Sandoz, Inc. | Other | LET-Letter | 2007-11-19T05:00:00Z | 2007 | 11 | 2008-04-04T00:37:46Z | 0 | 0 | 090000648042b100 | |||
| FDA-2007-P-0301-0003 | FDA | FDA-2007-P-0301 | Letter from FDA CFSAN to Barbara O. Schneeman | Other | Letter(s) | 2007-11-16T05:00:00Z | 2007 | 11 | 2025-03-13T16:02:17Z | 0 | 0 | 090000648042b62b | |||
| FDA-2007-N-0035-0002 | FDA | FDA-2007-N-0035 | Number not used | Other | ACK-Acknowledgement Letter | 2007-11-15T05:00:00Z | 2007 | 11 | 2008-04-04T00:35:32Z | 0 | 0 | 09000064804295b6 | |||
| FDA-2007-V-0021-0001 | FDA | FDA-2007-V-0021 | Acknowledgement Letter to Mountain Megabytes Inc. | Other | ACK-Acknowledgement Letter | 2007-11-15T05:00:00Z | 2007 | 11 | 2008-04-10T10:55:28Z | 0 | 0 | 0900006480429425 | |||
| FDA-2000-N-0190-0017 | FDA | Egg Safety Action Plan FDA-2000-N-0190 | Renee J. Wheeler | Other | MM-Memorandum of Meeting | 2007-11-15T05:00:00Z | 2007 | 11 | 2008-04-25T01:18:09Z | 0 | 0 | 09000064804d4090 | |||
| FDA-2005-D-0227-0016 | FDA | Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004; Guidance (Edition 2) FDA-2005-D-0227 | FDA/CFSAN Response to Patricia Faison (Kellen Company) - Answer | Other | Answer | 2007-11-14T05:00:00Z | 2007 | 11 | 2012-03-14T00:35:26Z | 0 | 0 | 09000064804420a0 | |||
| FDA-2005-D-0227-0015 | FDA | Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004; Guidance (Edition 2) FDA-2005-D-0227 | FDA/CFSAN Response to Jesper Korning (AAK) - Answer | Other | Answer | 2007-11-14T05:00:00Z | 2007 | 11 | 2012-03-14T00:27:33Z | 0 | 0 | 090000648044209e | |||
| FDA-2007-P-0418-0001 | FDA | FDA-2007-P-0418 | FDA/DDM to Cobalt Laboratories Inc. and Cobalt Pharmaceuticals Inc. | Other | ACK-Acknowledgement Letter | 2007-11-13T05:00:00Z | 2007 | 11 | 2008-04-04T00:38:17Z | 0 | 0 | 090000648042da5d |
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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);