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

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86 rows where docket_id = "FDA-2010-N-0621" and posted_year = 2011 sorted by posted_date descending

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posted_year 1

  • 2011 · 86 ✖

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2010-N-0621-0544 FDA None FDA-2010-N-0621 Decision of the Commissioner re Proposal to Withdraw Approval for the Breast Cancer Indication for Bevacizumab (Avastin) November 18, 2011 - Commissioner's Decision Other Commissioners Decision 2011-11-21T05:00:00Z 2011 11 2011-11-21T05:00:00Z   2013-07-28T00:08:47Z   0 0 0900006480f707b0
FDA-2010-N-0621-0538 FDA None FDA-2010-N-0621 Proposal to Withdraw Approval for the Breast Cancer Indication for Bevacizumab (Avastin) Public Hearing June 29, 2011 - Transcript Other Transcript(s) 2011-11-03T04:00:00Z 2011 11 2011-11-03T04:00:00Z   2011-11-03T20:58:33Z   0 0 0900006480f659ad
FDA-2010-N-0621-0537 FDA None FDA-2010-N-0621 Proposal to Withdraw Approval for the Breast Cancer Indication for Bevacizumab (Avastin) Public Hearing, June 28, 2011 - Transcript Other Transcript(s) 2011-11-03T04:00:00Z 2011 11 2011-11-03T04:00:00Z   2011-11-03T20:49:56Z   0 0 0900006480f65986
FDA-2010-N-0621-0535 FDA None FDA-2010-N-0621 Dr. Midthun to Michael Labson, September 27, 2011, Email Message - Electronic Letter Other Electronic Letter 2011-10-20T04:00:00Z 2011 10 2011-10-20T04:00:00Z   2011-10-20T15:59:55Z   0 0 0900006480f56f36
FDA-2010-N-0621-0481 FDA None FDA-2010-N-0621 Terrence D. Kalley, Freedom of Access to Medicines - Testimony Other Testimony 2011-08-16T04:00:00Z 2011 8 2011-08-16T04:00:00Z   2011-08-16T21:41:13Z   0 0 0900006480ed3aef
FDA-2010-N-0621-0479 FDA None FDA-2010-N-0621 FDA/CDER Post-Hearing Submission Supporting CDER’s Proposal, August 4, 2011 - Background Material Other Background Material 2011-08-04T04:00:00Z 2011 8 2011-08-04T04:00:00Z   2011-08-05T00:30:20Z   0 0 0900006480ed6bdb
FDA-2010-N-0621-0474 FDA None FDA-2010-N-0621 Christi C. Turnage - Testimony Other Testimony 2011-08-04T04:00:00Z 2011 8 2011-08-04T04:00:00Z   2013-08-11T03:16:27Z   0 0 0900006480ed65d6
FDA-2010-N-0621-0477 FDA None FDA-2010-N-0621 FDA/CDER Counsel, re Avastin Submission Under Seal (Addendum), August 4, 2011 - Letter Other Electronic Letter 2011-08-04T04:00:00Z 2011 8 2011-08-04T04:00:00Z   2011-08-04T21:07:05Z   0 0 0900006480ed6bd4
FDA-2010-N-0621-0467 FDA None FDA-2010-N-0621 Elizabeth Cleary, RN - Testimony Other Testimony 2011-08-04T04:00:00Z 2011 8 2011-08-04T04:00:00Z   2013-07-27T23:59:29Z   0 0 0900006480ecd8ef
FDA-2010-N-0621-0478 FDA None FDA-2010-N-0621 Genentech, Inc. (Covington & Burling LLP) Post-Hearing Submission, August 4, 2011 - Background Material Other Background Material 2011-08-04T04:00:00Z 2011 8 2011-08-04T04:00:00Z   2013-07-28T00:00:16Z   0 0 0900006480ed7758
FDA-2010-N-0621-0463 FDA None FDA-2010-N-0621 Genentech, Inc., (Covington & Burling LLP), July 25, 2011 - Request for Extension Other Request for Extension of Time in which to file a document 2011-08-03T04:00:00Z 2011 8 2011-08-03T04:00:00Z   2013-08-11T04:46:57Z   0 0 0900006480eccda7
FDA-2010-N-0621-0460 FDA None FDA-2010-N-0621 FDA/OC Office of Chief Counsel to the Presiding Officer, Center for Biologics Evaluation and Research (Dr. Midthun) re Avastin Submission Under Seal, August 3, 2011 - Letter Other Electronic Letter 2011-08-03T04:00:00Z 2011 8 2011-08-03T04:00:00Z   2011-08-03T23:37:00Z   0 0 0900006480ed6192
FDA-2010-N-0621-0459 FDA None FDA-2010-N-0621 Dr. Midthun to Counsel, August 3, 2011 - Letter Other Letter(s) 2011-08-03T04:00:00Z 2011 8 2011-08-03T04:00:00Z   2011-08-03T23:28:29Z   0 0 0900006480ed6190
FDA-2010-N-0621-0458 FDA None FDA-2010-N-0621 FDA/OC Office of Chief Counsel to the Presiding Officer, Center for Biologics Evaluation and Research (Dr. Midthun), August 2, 2011 - Letter Other Letter(s) 2011-08-02T04:00:00Z 2011 8 2011-08-02T04:00:00Z   2013-08-11T04:47:02Z   0 0 0900006480ed413a
FDA-2010-N-0621-0457 FDA None FDA-2010-N-0621 FDA/OC Office of Chief Counsel to the Presiding Officer, Center for Biologics Evaluation and Research (Dr. Midthun), July 29, 2011 - Letter Other Letter(s) 2011-08-01T04:00:00Z 2011 8 2011-08-01T04:00:00Z   2013-07-27T23:59:42Z   0 0 0900006480ed1415
FDA-2010-N-0621-0456 FDA None FDA-2010-N-0621 Dr. Midthun to Counsel, July 26, 2011 - Letter Other Letter(s) 2011-07-27T04:00:00Z 2011 7 2011-07-27T04:00:00Z   2011-07-27T21:57:58Z   0 0 0900006480ece10c
FDA-2010-N-0621-0453 FDA None FDA-2010-N-0621 FDA/OC Office of Legislation to Charoltte, Nortrh Carolina Constutient (Senator Richard Burr) - Letter Other Letter(s) 2011-07-21T04:00:00Z 2011 7 2011-07-21T04:00:00Z   2011-07-21T15:37:47Z   0 0 0900006480ec1375
FDA-2010-N-0621-0450 FDA None FDA-2010-N-0621 FDA/OC Office of Legislation to the Honorable David Vitter - Letter Other Letter(s) 2011-07-21T04:00:00Z 2011 7 2011-07-21T04:00:00Z   2011-07-21T15:42:30Z   0 0 0900006480ec1360
FDA-2010-N-0621-0444 FDA None FDA-2010-N-0621 FDA/OC Office of Legislation to the Honorable Rodney P. Frelinghuysen - Letter Other Letter(s) 2011-07-21T04:00:00Z 2011 7 2011-07-21T04:00:00Z   2011-07-21T15:22:29Z   0 0 0900006480ec1302
FDA-2010-N-0621-0447 FDA None FDA-2010-N-0621 FDA/OC Office of Legislation to the Honorable John Barrasso, M.D. - Letter Other Letter(s) 2011-07-21T04:00:00Z 2011 7 2011-07-21T04:00:00Z   2011-07-21T15:44:35Z   0 0 0900006480ec1321
FDA-2010-N-0621-0448 FDA None FDA-2010-N-0621 FDA/OC Office of Legislation to the Honorable Roger F. Wicker - Letter Other Letter(s) 2011-07-21T04:00:00Z 2011 7 2011-07-21T04:00:00Z   2011-07-21T15:44:00Z   0 0 0900006480ec133a
FDA-2010-N-0621-0451 FDA None FDA-2010-N-0621 FDA/OC Office of Legislation to the Honorable Thad Cochran - Letter Other Letter(s) 2011-07-21T04:00:00Z 2011 7 2011-07-21T04:00:00Z   2011-07-21T15:41:59Z   0 0 0900006480ec1366
FDA-2010-N-0621-0443 FDA None FDA-2010-N-0621 FDA/OC Office of Legislation to the Honorable Carl Levin - Letter Other Letter(s) 2011-07-21T04:00:00Z 2011 7 2011-07-21T04:00:00Z   2011-07-21T15:20:15Z   0 0 0900006480ec1300
FDA-2010-N-0621-0449 FDA None FDA-2010-N-0621 FDA/OC Office of Legislation to the Honorable Jack Kingston - Letter Other Letter(s) 2011-07-21T04:00:00Z 2011 7 2011-07-21T04:00:00Z   2011-07-21T15:43:12Z   0 0 0900006480ec133f
FDA-2010-N-0621-0442 FDA None FDA-2010-N-0621 FDA/OC Office of Legislation to the Honorable Gary C. Peters - Letter Other Letter(s) 2011-07-21T04:00:00Z 2011 7 2011-07-21T04:00:00Z   2011-07-21T15:20:41Z   0 0 0900006480ec12fe
FDA-2010-N-0621-0445 FDA None FDA-2010-N-0621 FDA/OC Office of Legislation to the Honorable Joseph I Lieberman - Letter Other Letter(s) 2011-07-21T04:00:00Z 2011 7 2011-07-21T04:00:00Z   2011-07-21T15:45:44Z   0 0 0900006480ec131d
FDA-2010-N-0621-0454 FDA None FDA-2010-N-0621 FDA/OC Office of Legislation to the Honorable Daniel Webster - Letter Other Letter(s) 2011-07-21T04:00:00Z 2011 7 2011-07-21T04:00:00Z   2011-07-21T15:39:41Z   0 0 0900006480ec1398
FDA-2010-N-0621-0446 FDA None FDA-2010-N-0621 FDA/OC Office of Legislation to the Honorable Ileana Lehtinen - Letter Other Letter(s) 2011-07-21T04:00:00Z 2011 7 2011-07-21T04:00:00Z   2011-07-21T15:45:08Z   0 0 0900006480ec131f
FDA-2010-N-0621-0452 FDA None FDA-2010-N-0621 FDA/OC Office of Legislation to Madison, Alabama Constutient (Senator Jeff Sessions) - Letter Other Letter(s) 2011-07-21T04:00:00Z 2011 7 2011-07-21T04:00:00Z   2011-07-21T15:41:25Z   0 0 0900006480ec136e
FDA-2010-N-0621-0441 FDA None FDA-2010-N-0621 FDA/OC Office of Legislation Response to the Honorable Gregg Harper - Letter Other Letter(s) 2011-07-21T04:00:00Z 2011 7 2011-07-21T04:00:00Z   2011-07-21T15:21:09Z   0 0 0900006480ec12fc
FDA-2010-N-0621-0429 FDA None FDA-2010-N-0621 Genentech - Transcript Other Transcript(s) 2011-07-11T04:00:00Z 2011 7 2011-07-11T04:00:00Z   2013-07-27T23:57:25Z   0 0 0900006480eb83a4
FDA-2010-N-0621-0421 FDA None FDA-2010-N-0621 Voting Results from Advisory Committee Members at Hearing on June 29, 2011 - List Other List (LST) 2011-07-05T04:00:00Z 2011 7 2011-07-05T04:00:00Z   2011-07-05T16:56:42Z   0 0 0900006480eb9011
FDA-2010-N-0621-0420 FDA None FDA-2010-N-0621 Dr. Midthun Response to Dr. Brown-Beasley, July 5, 2011 - E-Letter Other Electronic Letter 2011-07-05T04:00:00Z 2011 7 2011-07-05T04:00:00Z   2011-07-05T16:46:15Z   0 0 0900006480eb900f
FDA-2010-N-0621-0419 FDA None FDA-2010-N-0621 Dr. Midthun Response to Patricia Howard, June 30, 2011 - E-Letter Other Electronic Letter 2011-07-05T04:00:00Z 2011 7 2011-07-05T04:00:00Z   2011-07-05T16:43:01Z   0 0 0900006480eb8fe8
FDA-2010-N-0621-0360 FDA None FDA-2010-N-0621 Avastin - "Referenced Slides" - [Proposal To Withdraw Approval for the Breast Cancer Indication for Bevacizumab; Hearing] Other Petition(s) 2011-06-30T04:00:00Z 2011 6     2011-06-30T19:02:57Z   0 0 0900006480eb76b2
FDA-2010-N-0621-0359 FDA None FDA-2010-N-0621 Avastin Final Presentation - "Administrative Hearing Proposal to Withdraw Accelerated Approval of Avastin for 1st Line Metastatic Breast Cancer" - [Proposal To Withdraw Approval for the Breast Cancer Indication for Bevacizumab; Hearing] Other Presentation 2011-06-30T04:00:00Z 2011 6 2011-06-30T04:00:00Z   2011-06-30T18:55:45Z   0 0 0900006480eb768e
FDA-2010-N-0621-0369 FDA None FDA-2010-N-0621 FDA/OC Memo to the Division of Dockets Management, June 30, 2011 - Memorandum Other Memorandum 2011-06-30T04:00:00Z 2011 6 2011-06-30T04:00:00Z   2013-07-27T23:57:20Z   0 0 0900006480eb7795
FDA-2010-N-0621-0343 FDA None FDA-2010-N-0621 Dr. Midthun to Counsel, June 27, 2011 - Letter Other Letter(s) 2011-06-29T04:00:00Z 2011 6 2011-06-29T04:00:00Z   2011-06-29T19:48:31Z   0 0 0900006480eb67f8
FDA-2010-N-0621-0342 FDA None FDA-2010-N-0621 FDA/OC (CDER) to the Presiding Officer, Center for Biologics Evaluation and Research (Dr. Midthun), June 27, 2011 - Letter Other Letter(s) 2011-06-29T04:00:00Z 2011 6 2011-06-29T04:00:00Z   2011-06-29T19:45:12Z   0 0 0900006480eb67f6
FDA-2010-N-0621-0308 FDA None FDA-2010-N-0621 FDA/OC (CDER) to the Presiding Officer, Center for Biologics Evaluation and Research (Dr. Midthun), June 24, 2011 - Letter Other Letter(s) 2011-06-24T04:00:00Z 2011 6 2011-06-24T04:00:00Z   2011-06-24T20:00:09Z   0 0 0900006480eb35cc
FDA-2010-N-0621-0298 FDA None FDA-2010-N-0621 FDA/OC (CDER) to the Presiding Officer, Center for Biologics Evaluation and Research (Dr. Midthun), June 23, 2011 - Letter Other Letter(s) 2011-06-23T04:00:00Z 2011 6     2011-06-23T19:13:53Z   0 0 0900006480ead27d
FDA-2010-N-0621-0299 FDA None FDA-2010-N-0621 FDA Commissioner of Food and Drugs re Advisory Committee Quorum - Memo to File Other Memorandum 2011-06-23T04:00:00Z 2011 6 2011-06-23T04:00:00Z   2011-06-23T22:42:32Z   0 0 0900006480ead3dc
FDA-2010-N-0621-0195 FDA None FDA-2010-N-0621 Dr. Midthun to Counsel, June 20, 2011 - Letter Other Letter(s) 2011-06-21T04:00:00Z 2011 6 2011-06-21T04:00:00Z   2011-06-21T12:31:38Z   0 0 0900006480e69ad5
FDA-2010-N-0621-0194 FDA None FDA-2010-N-0621 FDA/OC (CDER) to the Presiding Officer, Center for Biologics Evaluation and Research (Dr. Midthun), June 17, 2011 - Letter Other Letter(s) 2011-06-17T04:00:00Z 2011 6 2011-06-17T04:00:00Z   2011-06-17T21:13:03Z   0 0 0900006480e52568
FDA-2010-N-0621-0193 FDA None FDA-2010-N-0621 Genentech, Inc. (Covington & Burling LLP) to the Presiding Officer (Karen Midthun, M.D.), June 13, 2011 - Letter Other Letter(s) 2011-06-16T04:00:00Z 2011 6 2011-06-16T04:00:00Z   2013-08-11T03:15:21Z   0 0 0900006480e4f82f
FDA-2010-N-0621-0192 FDA None FDA-2010-N-0621 FDA/OC (CDER) to the Presiding Officer, Center for Biologics Evaluation and Research (Dr. Midthun), June 3, 2011, re Presenters and Curricala Vitae/Biographies - Letter Other Letter(s) 2011-06-16T04:00:00Z 2011 6 2011-06-16T04:00:00Z   2011-06-20T14:09:52Z   0 0 0900006480e51e22
FDA-2010-N-0621-0191 FDA None FDA-2010-N-0621 FDA/OC (CDER) to the Presiding Officer, Center for Biologics Evaluation and Research (Dr. Midthun), June 15, 2011 - Letter Other Letter(s) 2011-06-15T04:00:00Z 2011 6 2011-06-15T04:00:00Z   2011-06-16T00:38:59Z   0 0 0900006480e500ff
FDA-2010-N-0621-0161 FDA None FDA-2010-N-0621 Test FDMS 3.5 release w/added public submission no submitter's info Supporting & Related Material   2011-06-14T00:00:00Z 2011 6     2024-11-07T22:32:19Z   0 1 0900006480e50287
FDA-2010-N-0621-0155 FDA None FDA-2010-N-0621 FDA/OC (CDER) to the Presiding Officer, Center for Biologics Evaluation and Research (Dr. Midthun), May 27, 2011, re Presenters and Curricala Vitae/Biographies - Letter Other LET-Letter 2011-05-31T04:00:00Z 2011 5 2011-05-31T04:00:00Z   2011-06-14T20:59:13Z   0 0 0900006480e34316
FDA-2010-N-0621-0156 FDA None FDA-2010-N-0621 Appendix 15 Substitution of the "Statistical Review and Evaluation” document in Appendix 15 (CDER’s Review of sBLA STN125085\191, AVADO) to the CDER May 13, 2011 submission (ref FDA-2010-N-0621-0145.15) Supporting & Related Material RPT-Report (Supporting and Related Material) 2011-05-31T04:00:00Z 2011 5     2011-06-21T15:14:52Z   0 0 0900006480e3711a
FDA-2010-N-0621-0154 FDA None FDA-2010-N-0621 Genentech, Inc., (Covington & Burling LLP) to Karen Midthun, M.D., Presiding Officer, re Witness List and Curriculum Vitae - Letter Other LET-Letter 2011-05-27T04:00:00Z 2011 5 2011-05-27T04:00:00Z   2013-07-27T23:54:24Z   0 0 0900006480e34356
FDA-2010-N-0621-0152 FDA None FDA-2010-N-0621 Dr. Midthun to Counsel, May 25, 2011 - Letter Other LET-Letter 2011-05-26T04:00:00Z 2011 5 2011-05-26T04:00:00Z   2013-07-27T23:54:13Z   0 0 0900006480e32f1a
FDA-2010-N-0621-0150 FDA None FDA-2010-N-0621 Genentech, Inc. (Covington & Burling LLP) to the Presiding Officer (Karen Midthun, M.D.), May 18, 2011 - Letter Other LET-Letter 2011-05-26T04:00:00Z 2011 5 2011-05-26T04:00:00Z   2013-07-27T23:53:27Z   0 0 0900006480d52ad6
FDA-2010-N-0621-0151 FDA None FDA-2010-N-0621 Genentech, Inc. (Covington & Burling LLP) to the Presiding Officer (Karen Midthun, M.D.), May 20, 2011 - Letter Other LET-Letter 2011-05-26T04:00:00Z 2011 5 2011-05-26T04:00:00Z   2013-08-11T04:45:57Z   0 0 0900006480dd3015
FDA-2010-N-0621-0148 FDA None FDA-2010-N-0621 FDA/OC Office of Chief Counsel to the Presiding Officer, Center for Biologics Evaluation and Research (Dr. Midthun), May 17, 2011 - Letter Other LET-Letter 2011-05-17T04:00:00Z 2011 5 2011-05-17T04:00:00Z   2013-08-11T01:41:41Z   0 0 0900006480d1081a
FDA-2010-N-0621-0147 FDA None FDA-2010-N-0621 Genentech, Inc. (Covington & Burling LLP) to the Presiding Officer (Karen Midthun, M.D.), May 16, 2011 - Letter Other LET-Letter 2011-05-16T04:00:00Z 2011 5 2011-05-16T04:00:00Z   2013-07-27T23:53:07Z   0 0 0900006480cd80e9
FDA-2010-N-0621-0146 FDA None FDA-2010-N-0621 Genentech, Inc., (Covington & Burling LLP) - Pre-Hearing Summary of Evidence and Arguments Other AR-Argument 2011-05-16T04:00:00Z 2011 5 2011-05-16T04:00:00Z   2013-07-27T23:53:02Z   0 0 0900006480c7a3b5
FDA-2010-N-0621-0145 FDA None FDA-2010-N-0621 Appendices List (1-35) - [FDA/CDER, Summary of Arguments Supporting CDER’s Proposal to Withdraw Approval of Avastin’s Indication for the Treatment of Metastatic Breast Cancer - Summary of Agruments] Supporting & Related Material Reference (internal unless indicated) 2011-05-16T04:00:00Z 2011 5     2018-09-10T22:40:02Z   0 0 0900006480c7a7c3
FDA-2010-N-0621-0143 FDA None FDA-2010-N-0621 Proposal To Withdraw Approval for the Breast Cancer Indication for Bevacizumab; Hearing Notice NH-Notice of Hearing 2011-05-11T04:00:00Z 2011 5 2011-05-11T04:00:00Z 2011-08-05T03:59:59Z 2011-08-03T23:59:42Z 2011-11539 0 0 0900006480c6c051
FDA-2010-N-0621-0142 FDA None FDA-2010-N-0621 Dr. Midthun Response to Patricia Howard, May 6, 2011 - Letter Other LET-Letter 2011-05-09T04:00:00Z 2011 5 2011-05-09T04:00:00Z   2011-05-09T20:43:44Z   0 0 0900006480c4386f
FDA-2010-N-0621-0140 FDA None FDA-2010-N-0621 Dr. Midthun to Counsel, May 6, 2011 - Letter Other LET-Letter 2011-05-09T04:00:00Z 2011 5 2011-05-09T04:00:00Z   2011-05-09T20:27:46Z   0 0 0900006480c4386d
FDA-2010-N-0621-0141 FDA None FDA-2010-N-0621 Dr. Midthun to the Oncologic Drugs Advisory Committee Members, May 6, 2011 - Letter Other LET-Letter 2011-05-09T04:00:00Z 2011 5 2011-05-09T04:00:00Z   2011-05-18T15:45:04Z   0 0 0900006480c4386e
FDA-2010-N-0621-0138 FDA None FDA-2010-N-0621 Dr. Midthun to Counsel, May 2, 2011 - Letter Other LET-Letter 2011-05-04T04:00:00Z 2011 5 2011-05-04T04:00:00Z   2011-05-04T18:36:48Z   0 0 0900006480c3f070
FDA-2010-N-0621-0134 FDA None FDA-2010-N-0621 Genentech, Inc. (Covington & Burling LLP) Response to FDA/CDER, April 8, 2011 - Letter Other LET-Letter 2011-04-19T04:00:00Z 2011 4 2011-04-19T04:00:00Z   2013-08-11T04:45:02Z   0 0 0900006480c1f843
FDA-2010-N-0621-0135 FDA None FDA-2010-N-0621 Genentech, Inc. (Covington & Burling LLP) Response to FDA/CDER, April 13, 2011 - Letter Other LET-Letter 2011-04-19T04:00:00Z 2011 4 2011-04-19T04:00:00Z   2013-07-27T23:50:15Z   0 0 0900006480c2a4a7
FDA-2010-N-0621-0132 FDA None FDA-2010-N-0621 Genentech, Inc. (Covington & Burling LLP) to FDA/CDER - re Joint Statement of Undisputed Facts and Select Issues in Dispute of the FDA Center for Drug Evaluation and Research and Genentech, Inc. - Letter Other LET-Letter 2011-04-19T04:00:00Z 2011 4 2011-04-19T04:00:00Z   2013-07-27T23:49:39Z   0 0 0900006480c1ea22
FDA-2010-N-0621-0136 FDA None FDA-2010-N-0621 Dr. Midthun to Counsel, April 18, 2011 - Letter Other LET-Letter 2011-04-19T04:00:00Z 2011 4 2011-04-19T04:00:00Z   2013-07-27T23:50:44Z   0 0 0900006480c3020b
FDA-2010-N-0621-0133 FDA None FDA-2010-N-0621 Genentech, Inc. (Covington & Burling LLP) and FDA/CDER Joint Response to the Presiding Officer Dr. Karen Midthun, April 7, 2011 - Letter Other LET-Letter 2011-04-19T04:00:00Z 2011 4 2011-04-19T04:00:00Z   2013-08-11T03:14:06Z   0 0 0900006480c1ea2b
FDA-2010-N-0621-0130 FDA None FDA-2010-N-0621 Genentech, Inc. (Covington & Burling LLP) Response to FDA/CDER, April 5, 2011 - Letter Other Letter(s) 2011-04-19T04:00:00Z 2011 4 2011-04-19T04:00:00Z   2013-08-11T01:40:57Z   0 0 0900006480c1e3c2
FDA-2010-N-0621-0131 FDA None FDA-2010-N-0621 Genentech, Inc. (Covington & Burling LLP) - Electronic Letter Other ELET-Electronic Letter 2011-04-19T04:00:00Z 2011 4 2011-04-19T04:00:00Z   2013-08-11T03:14:06Z   0 0 0900006480c1ea1e
FDA-2010-N-0621-0129 FDA None FDA-2010-N-0621 FDA Office of the Ombudsman Repsonse to Covington & Burling LLP, April 13, 2011 - Letter Other LET-Letter 2011-04-14T04:00:00Z 2011 4 2011-04-14T04:00:00Z   2011-06-14T20:15:43Z   0 0 0900006480c2cb22
FDA-2010-N-0621-0128 FDA None FDA-2010-N-0621 FDA/OC (CDER) to the Presiding Officer, Center for Biologics Evaluation and Research (Dr. Midthun), April 11, 2011 - Letter Other LET-Letter 2011-04-12T04:00:00Z 2011 4 2011-04-12T04:00:00Z   2013-07-27T23:49:55Z   0 0 0900006480c22ccf
FDA-2010-N-0621-0127 FDA None FDA-2010-N-0621 Center for Drug Evaluation and Research - "CDER's Statement of Questions Presented" - Reply Statement Other S-Reply Statement 2011-04-12T04:00:00Z 2011 4 2011-04-12T04:00:00Z   2013-07-27T23:49:54Z   0 0 0900006480c2225a
FDA-2010-N-0621-0126 FDA None FDA-2010-N-0621 FDA/OC (CDER) to the Presiding Officer, Center for Biologics Evaluation and Research (Dr. Midthun), April 7, 2011 - Letter Other LET-Letter 2011-04-07T04:00:00Z 2011 4 2011-04-07T04:00:00Z   2013-07-27T23:49:40Z   0 0 0900006480c1ed74
FDA-2010-N-0621-0125 FDA None FDA-2010-N-0621 Dr. Midthun to Covington & Burling LLP(Michael Labson, Esq.), March 29, 2011 - Letter Other LET-Letter 2011-04-01T04:00:00Z 2011 4 2011-04-01T04:00:00Z   2011-06-14T20:14:40Z   0 0 0900006480c193dd
FDA-2010-N-0621-0124 FDA None FDA-2010-N-0621 Genentech, Inc. (Covington & Burling LLP) Response to FDA/CDER, March 10, 2011 - Letter Other Letter(s) 2011-03-28T04:00:00Z 2011 3 2010-12-16T05:00:00Z   2013-08-11T03:13:50Z   0 0 0900006480c0fbfc
FDA-2010-N-0621-0122 FDA None FDA-2010-N-0621 FDA/OC Office of Chief Counsel to the Presiding Officer, Center for Biologics Evaluation and Research (Dr. Midthun), March 22, 2011 - Letter Other LET-Letter 2011-03-22T04:00:00Z 2011 3 2011-03-22T04:00:00Z   2011-06-14T20:14:16Z   0 0 0900006480c0d522
FDA-2010-N-0621-0121 FDA None FDA-2010-N-0621 Dr. Midthun to Counsel, March 10, 2011 - Letter Other Letter(s) 2011-03-10T05:00:00Z 2011 3 2011-03-10T05:00:00Z   2013-08-11T03:13:35Z   0 0 0900006480c05591
FDA-2010-N-0621-0120 FDA None FDA-2010-N-0621 FDA/OC and Genentech, Inc. (Covington & Burling) - Request for Extension of Time Other EXT-Request for Extension Comment Due Date 2011-03-07T05:00:00Z 2011 3 2011-03-07T05:00:00Z   2013-08-11T04:44:32Z   0 0 0900006480c02a24
FDA-2010-N-0621-0118 FDA None FDA-2010-N-0621 Dr. Midthun to Counsel, March 3, 2011 - Letter Other Letter(s) 2011-03-03T05:00:00Z 2011 3 2011-03-03T05:00:00Z   2011-06-21T12:35:05Z   0 0 0900006480bfef5c
FDA-2010-N-0621-0067 FDA None FDA-2010-N-0621 Dr. Midthun to Counsel, February 23, 2011 - Letter Other LET-Letter 2011-02-24T05:00:00Z 2011 2 2011-02-24T05:00:00Z   2011-03-03T21:55:11Z   0 0 0900006480bf7086
FDA-2010-N-0621-0052 FDA None FDA-2010-N-0621 Attachment 9 - "Clinical Review, Edvardas Kaminskas, Robert Lechleider, NDA22-065, Ixempra, ixabepilone" - [Genentech, Inc. - Comment] re FDA-2010-N-0621-0014 Supporting & Related Material EREG-Electronic Regulation from Form Supporting and Related Material) 2011-02-23T05:00:00Z 2011 2     2012-03-24T19:36:28Z   0 0 0900006480bcca25
FDA-2010-N-0621-0015 FDA None FDA-2010-N-0621 Attachment 1 - "Prescribing Information, Avastin (Bevacizumab)" - [Genentech, Inc. - Comment] re FDA-2010-N-0621-0014 Supporting & Related Material EREG-Electronic Regulation from Form Supporting and Related Material) 2011-01-24T05:00:00Z 2011 1     2012-03-24T19:34:01Z   0 0 0900006480bcc0f8
FDA-2010-N-0621-0018 FDA None FDA-2010-N-0621 Attachment 11 - "CDER Medical Reviews" - [Genentech, Inc. - Comment] re FDA-2010-N-0621-0014 Supporting & Related Material EREG-Electronic Regulation from Form Supporting and Related Material) 2011-01-24T05:00:00Z 2011 1     2012-03-24T19:34:37Z   0 0 0900006480bcca29
FDA-2010-N-0621-0016 FDA None FDA-2010-N-0621 Attachment 2 - "Eastern Cooperative Oncology Group Memo dated August 23. 2005; Addendum #8, for E2100, A Randomized Phase III Trial of Paclitaxel versus Paclitaxel plus Bevacizumab (rhuMAb VEGF) as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer" - [Genentech, Inc. - Comment] re FDA-2010-N-0621-0014 Supporting & Related Material EREG-Electronic Regulation from Form Supporting and Related Material) 2011-01-24T05:00:00Z 2011 1     2012-03-24T19:33:25Z   0 0 0900006480bcca10
FDA-2010-N-0621-0017 FDA None FDA-2010-N-0621 Attachment 4 - "Briefing Book Oncology Drugs Advisory Committee Meeting, Avastin (Bevacizumab)" - [Genentech, Inc. - Comment] re FDA-2010-N-0621-0014 Supporting & Related Material EREG-Electronic Regulation from Form Supporting and Related Material) 2011-01-24T05:00:00Z 2011 1     2012-03-24T19:32:27Z   0 0 0900006480bcca14

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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);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;