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73 rows where docket_id = "FDA-1999-D-0081" sorted by posted_date descending

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FDA-1999-D-0081-0083 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 30 Martineau et al 1997 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:44:44Z   0 0 090000648430e1e5
FDA-1999-D-0081-0060 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 7 Vanin et al 1994 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:49:05Z   0 0 090000648430e1be
FDA-1999-D-0081-0053 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference List Testing of Retrovial Vector re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:50:25Z   0 0 090000648430e0c9
FDA-1999-D-0081-0054 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 1 Donahue et al 1992 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:50:14Z   0 0 090000648430e0ca
FDA-1999-D-0081-0080 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 27 Mohanal et al 2016 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:45:24Z   0 0 090000648430e1e2
FDA-1999-D-0081-0072 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 19 Farley et al 2015 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:46:50Z   0 0 090000648430e50e
FDA-1999-D-0081-0052 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Other Guidance 2020-01-30T05:00:00Z 2020 1 2020-01-30T05:00:00Z   2024-11-12T23:16:47Z   1 0 090000648430ded7
FDA-1999-D-0081-0081 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 28 Scholler et al 2012 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:45:11Z   0 0 090000648430e1e3
FDA-1999-D-0081-0074 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 21 Rowe et al 1970 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:46:28Z   0 0 090000648430e510
FDA-1999-D-0081-0073 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 20 Bassin et al 1971 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:46:40Z   0 0 090000648430e50f
FDA-1999-D-0081-0077 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 24 Gene Therapy Clinical Trials – Observing Subjects for Delayed Adverse Events November 2006 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:45:57Z   0 0 090000648430e52a
FDA-1999-D-0081-0058 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 5 Gunter et al 1993 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:49:23Z   0 0 090000648430e1bc
FDA-1999-D-0081-0065 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 12 Wilson et al 1997 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:48:18Z   0 0 090000648430e1c3
FDA-1999-D-0081-0057 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 4 Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:49:45Z   0 0 090000648430e1bb
FDA-1999-D-0081-0079 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 26 McGarrityet al 2013 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:45:35Z   0 0 090000648430e572
FDA-1999-D-0081-0066 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 13 Sakuma et al 2012 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:48:08Z   0 0 090000648430e508
FDA-1999-D-0081-0070 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 17 Lander et al 1984 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:47:08Z   0 0 090000648430e50c
FDA-1999-D-0081-0056 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 3 Kahn et al 2018 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:49:53Z   0 0 090000648430e1ba
FDA-1999-D-0081-0082 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 29 Long et al 1998 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:44:59Z   0 0 090000648430e1e4
FDA-1999-D-0081-0061 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 8 Cornetta et al 1991 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:48:56Z   0 0 090000648430e1bf
FDA-1999-D-0081-0075 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 22 Sastry et al 2005 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:46:18Z   0 0 090000648430e511
FDA-1999-D-0081-0051 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry; Availability Notice Notice of Availability 2020-01-30T05:00:00Z 2020 1 2020-01-30T05:00:00Z   2020-01-30T15:00:54Z 2020-01700 0 0 090000648430aa3d
FDA-1999-D-0081-0068 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 15 Fuller et al 2001 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:47:26Z   0 0 090000648430e50a
FDA-1999-D-0081-0062 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 9 Kantoff et al 1986 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:48:48Z   0 0 090000648430e1c0
FDA-1999-D-0081-0076 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 23 Sastry et al 2003 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:46:06Z   0 0 090000648430e529
FDA-1999-D-0081-0055 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 2 Fields Chapter 47 Retroviridae re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:50:01Z   0 0 090000648430e0cb
FDA-1999-D-0081-0071 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 18 Escarpe et al 2003 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:46:59Z   0 0 090000648430e50d
FDA-1999-D-0081-0064 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 11 Riviere 2014 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:48:28Z   0 0 090000648430e1c2
FDA-1999-D-0081-0063 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 10 Briefing Document - Testing for Replication Competent Retrovirus RCR-Lentivirus RCL in Retroviral and Lentiviral Vector Based Gene Therapy Products re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:48:39Z   0 0 090000648430e1c1
FDA-1999-D-0081-0069 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 16 Wagner et al 2000 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:47:18Z   0 0 090000648430e50b
FDA-1999-D-0081-0078 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 25 Abina et al 2015 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:45:46Z   0 0 090000648430e52b
FDA-1999-D-0081-0059 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 6 Purcell et al 1996 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:49:15Z   0 0 090000648430e1bd
FDA-1999-D-0081-0067 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 14 Vannuci et al 2013 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:47:36Z   0 0 090000648430e509
FDA-1999-D-0081-0084 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 31 Miller et al 1985 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry Supporting & Related Material Background Material 2020-01-30T05:00:00Z 2020 1     2020-03-09T15:44:33Z   0 0 090000648430e1e6
FDA-1999-D-0081-0039 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Draft Guidances Relating to the Development of Human Gene Therapy Products; Availability; Extension of Comment Period Notice Extension of Comment Period 2018-09-06T04:00:00Z 2018 9 2018-09-06T04:00:00Z 2018-12-11T04:59:59Z 2018-12-11T02:01:53Z 2018-19303 0 0 09000064836af5fa
FDA-1999-D-0081-0038 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Request for Extension from Biotechnology Innovation Organization (BIO) Other Request for Extension 2018-08-07T04:00:00Z 2018 8 2018-08-07T04:00:00Z   2018-08-07T13:45:13Z   0 0 09000064835c5e93
FDA-1999-D-0081-0016 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 10 Briefing Document - Testing for Replication Competent Retrovirus RCR-Lentivirus RCL in Retroviral and Lentiviral Vector Based Gene Therapy Products re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:24:05Z   0 0 09000064834dd07f
FDA-1999-D-0081-0024 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 18 Escarpe et al 2003 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:22:41Z   0 0 09000064834dd911
FDA-1999-D-0081-0013 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 7 Vanin et al 1994 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:24:29Z   0 0 09000064834dd07c
FDA-1999-D-0081-0019 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 13 Sakuma et al 2012 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:23:33Z   0 0 09000064834dd90c
FDA-1999-D-0081-0022 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 16 Wagner et al 2000 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:23:03Z   0 0 09000064834dd90f
FDA-1999-D-0081-0025 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 19 Farley et al 2015 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:22:30Z   0 0 09000064834dd912
FDA-1999-D-0081-0009 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 3 Kahn et al 2018 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:25:07Z   0 0 09000064834dd078
FDA-1999-D-0081-0018 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 12 Wilson et al 1997 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:23:45Z   0 0 09000064834dd081
FDA-1999-D-0081-0023 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 17 Lander et al 1984 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:22:49Z   0 0 09000064834dd910
FDA-1999-D-0081-0026 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 20 Bassin et al 1971 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:22:20Z   0 0 09000064834dd913
FDA-1999-D-0081-0006 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference List Testing of Retroviral Vector re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:25:33Z   0 0 09000064834dd04d
FDA-1999-D-0081-0010 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 4 Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:24:56Z   0 0 09000064834dd079
FDA-1999-D-0081-0011 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 5 Gunter et al 1993 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:24:47Z   0 0 09000064834dd07a
FDA-1999-D-0081-0027 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 21 Rowe et al 1970 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:22:06Z   0 0 09000064834dd914
FDA-1999-D-0081-0020 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 14 Vannuci et al 2013 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:23:19Z   0 0 09000064834dd90d
FDA-1999-D-0081-0030 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 24 Gene Therapy Clinical Trials – Observing Subjects for Delayed Adverse Events November 2006 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:21:02Z   0 0 09000064834dd0c1
FDA-1999-D-0081-0014 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 8 Cornetta et al 1991 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:24:21Z   0 0 09000064834dd07d
FDA-1999-D-0081-0031 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 25 Abina et al 2015 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:20:52Z   0 0 09000064834dd0c2
FDA-1999-D-0081-0033 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 27 Mohanal et al 2016 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:20:31Z   0 0 09000064834dd0c4
FDA-1999-D-0081-0034 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 28 Scholler et al 2012 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:20:23Z   0 0 09000064834dd0c5
FDA-1999-D-0081-0021 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 15 Fuller et al 2001 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:23:10Z   0 0 09000064834dd90e
FDA-1999-D-0081-0007 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 1 Donahue et al 1992 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:25:25Z   0 0 09000064834dd04e
FDA-1999-D-0081-0015 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 9 Kantoff et al 1986 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:24:14Z   0 0 09000064834dd07e
FDA-1999-D-0081-0005 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Other Guidance 2018-07-12T04:00:00Z 2018 7 2018-07-12T04:00:00Z   2024-11-07T01:33:38Z   1 0 09000064834dd664
FDA-1999-D-0081-0032 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 26 McGarrityet al 2013 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:20:40Z   0 0 09000064834dd0c3
FDA-1999-D-0081-0008 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 2 Fields Chapter 47 Retroviridae re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:25:16Z   0 0 09000064834dd04f
FDA-1999-D-0081-0012 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 6 Purcell et al 1996 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:24:38Z   0 0 09000064834dd07b
FDA-1999-D-0081-0017 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 11 Riviere 2014 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:23:57Z   0 0 09000064834dd080
FDA-1999-D-0081-0029 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 23 Sastry et al 2003 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:21:12Z   0 0 09000064834dd0c0
FDA-1999-D-0081-0037 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 31 Miller et al 1985 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:19:54Z   0 0 09000064834dd0c8
FDA-1999-D-0081-0035 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 29 Long et al 1998 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:20:12Z   0 0 09000064834dd0c6
FDA-1999-D-0081-0028 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 22 Sastry et al 2005 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:21:26Z   0 0 09000064834dd915
FDA-1999-D-0081-0036 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Reference 30 Martineau et al 1997 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:20:03Z   0 0 09000064834dd0c7
FDA-1999-D-0081-0004 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Draft Guidance for Industry; Availability Notice Notice of Availability 2018-07-12T04:00:00Z 2018 7 2018-07-12T04:00:00Z   2018-07-12T17:26:33Z 2018-14868 0 0 09000064834d7d00
FDA-1999-D-0081-0003 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors Supporting & Related Material Guidance 2006-11-27T05:00:00Z 2006 11     2025-07-01T21:52:54Z   0 0 09000064804a6962
FDA-1999-D-0081-0002 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 "Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors;" Availability Notice Notice of Data Availability 2000-10-24T04:00:00Z 2000 10     2025-07-01T21:48:06Z 00-26670 0 0 09000064804a6961
FDA-1999-D-0081-0001 FDA Testing for Replication Competent Retrovirus in Retroviral FDA-1999-D-0081 Draft "Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors;" Availability Notice Notice of Data Availability 1999-11-03T05:00:00Z 1999 11 1999-11-03T05:00:00Z 2000-02-02T04:59:59Z 2025-07-01T20:17:52Z 99-28560 0 0 09000064804a694a

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