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withdrawn,object_id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-1999-D-0081-0039,FDA,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,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,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Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry,Supporting & Related Material,Background Material,2018-07-12T04:00:00Z,2018,7,,,2020-03-09T15:24:05Z,,0,0,09000064834dd07f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,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Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry,Supporting & Related Material,Background Material,2018-07-12T04:00:00Z,2018,7,,,2020-03-09T15:22:41Z,,0,0,09000064834dd911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,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Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry,Supporting & Related Material,Background Material,2018-07-12T04:00:00Z,2018,7,,,2020-03-09T15:24:29Z,,0,0,09000064834dd07c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,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Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry,Supporting & Related Material,Background Material,2018-07-12T04:00:00Z,2018,7,,,2020-03-09T15:23:33Z,,0,0,09000064834dd90c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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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