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

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34 rows where docket_id = "FDA-1999-D-0081" and posted_year = 2020 sorted by posted_date descending

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  • 2020 · 34 ✖

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-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

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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);