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withdrawn,object_id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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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