{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\", docket_id = \"FDA-1999-D-0081\" and posted_year = 2018 sorted by posted_date descending", "rows": [["FDA-1999-D-0081-0039", "FDA", "FDA-1999-D-0081", "Draft Guidances Relating to the Development of Human Gene Therapy\nProducts; 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", "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", null, "2018-08-07T13:45:13Z", null, 0, 0, "09000064835c5e93"], ["FDA-1999-D-0081-0016", "FDA", "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Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry", "Supporting & Related Material", "Background Material", "2018-07-12T04:00:00Z", 2018, 7, null, null, "2020-03-09T15:24:05Z", null, 0, 0, "09000064834dd07f"], ["FDA-1999-D-0081-0024", "FDA", "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Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry", "Supporting & Related Material", "Background Material", "2018-07-12T04:00:00Z", 2018, 7, null, null, "2020-03-09T15:22:41Z", null, 0, 0, "09000064834dd911"], ["FDA-1999-D-0081-0013", "FDA", "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Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry", "Supporting & Related Material", "Background Material", "2018-07-12T04:00:00Z", 2018, 7, null, null, "2020-03-09T15:24:29Z", null, 0, 0, "09000064834dd07c"], ["FDA-1999-D-0081-0019", "FDA", "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Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry", "Supporting & Related Material", "Background Material", "2018-07-12T04:00:00Z", 2018, 7, null, null, "2020-03-09T15:23:33Z", null, 0, 0, "09000064834dd90c"], ["FDA-1999-D-0081-0022", "FDA", "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, null, null, "2020-03-09T15:23:03Z", null, 0, 0, "09000064834dd90f"], ["FDA-1999-D-0081-0025", "FDA", "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, null, null, "2020-03-09T15:22:30Z", null, 0, 0, "09000064834dd912"], ["FDA-1999-D-0081-0009", "FDA", "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, null, null, "2020-03-09T15:25:07Z", null, 0, 0, "09000064834dd078"], ["FDA-1999-D-0081-0018", "FDA", "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, null, null, "2020-03-09T15:23:45Z", null, 0, 0, "09000064834dd081"], ["FDA-1999-D-0081-0023", "FDA", "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, null, null, "2020-03-09T15:22:49Z", null, 0, 0, "09000064834dd910"], ["FDA-1999-D-0081-0026", "FDA", "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, null, null, "2020-03-09T15:22:20Z", null, 0, 0, "09000064834dd913"], ["FDA-1999-D-0081-0006", "FDA", "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, null, null, "2020-03-09T15:25:33Z", null, 0, 0, "09000064834dd04d"], ["FDA-1999-D-0081-0010", "FDA", "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, null, null, "2020-03-09T15:24:56Z", null, 0, 0, "09000064834dd079"], ["FDA-1999-D-0081-0011", "FDA", "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, null, null, "2020-03-09T15:24:47Z", null, 0, 0, "09000064834dd07a"], ["FDA-1999-D-0081-0027", "FDA", "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, null, null, "2020-03-09T15:22:06Z", null, 0, 0, "09000064834dd914"], ["FDA-1999-D-0081-0020", "FDA", "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, null, null, "2020-03-09T15:23:19Z", null, 0, 0, "09000064834dd90d"], ["FDA-1999-D-0081-0030", "FDA", "FDA-1999-D-0081", "Reference 24  Gene Therapy Clinical Trials \u2013 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, null, null, "2020-03-09T15:21:02Z", null, 0, 0, "09000064834dd0c1"], ["FDA-1999-D-0081-0014", "FDA", "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, null, null, "2020-03-09T15:24:21Z", null, 0, 0, "09000064834dd07d"], ["FDA-1999-D-0081-0031", "FDA", "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, null, null, "2020-03-09T15:20:52Z", null, 0, 0, "09000064834dd0c2"], ["FDA-1999-D-0081-0033", "FDA", "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, null, null, "2020-03-09T15:20:31Z", null, 0, 0, "09000064834dd0c4"], ["FDA-1999-D-0081-0034", "FDA", "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, null, null, "2020-03-09T15:20:23Z", null, 0, 0, "09000064834dd0c5"], ["FDA-1999-D-0081-0021", "FDA", "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, null, null, "2020-03-09T15:23:10Z", null, 0, 0, "09000064834dd90e"], ["FDA-1999-D-0081-0007", "FDA", "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, null, null, "2020-03-09T15:25:25Z", null, 0, 0, "09000064834dd04e"], ["FDA-1999-D-0081-0015", "FDA", "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, null, null, "2020-03-09T15:24:14Z", null, 0, 0, "09000064834dd07e"], ["FDA-1999-D-0081-0005", "FDA", "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", null, "2024-11-07T01:33:38Z", null, 1, 0, "09000064834dd664"], ["FDA-1999-D-0081-0032", "FDA", "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, null, null, "2020-03-09T15:20:40Z", null, 0, 0, "09000064834dd0c3"], ["FDA-1999-D-0081-0008", "FDA", "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, null, null, "2020-03-09T15:25:16Z", null, 0, 0, "09000064834dd04f"], ["FDA-1999-D-0081-0012", "FDA", "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, null, null, "2020-03-09T15:24:38Z", null, 0, 0, "09000064834dd07b"], ["FDA-1999-D-0081-0017", "FDA", "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, null, null, "2020-03-09T15:23:57Z", null, 0, 0, "09000064834dd080"], ["FDA-1999-D-0081-0029", "FDA", "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, null, null, "2020-03-09T15:21:12Z", null, 0, 0, "09000064834dd0c0"], ["FDA-1999-D-0081-0037", "FDA", "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, null, null, "2020-03-09T15:19:54Z", null, 0, 0, "09000064834dd0c8"], ["FDA-1999-D-0081-0035", "FDA", "FDA-1999-D-0081", "Reference 29 Long et al 1998 re Testing of 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