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

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36 rows where docket_id = "FDA-1999-D-0081" and posted_year = 2018 sorted by posted_date descending

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  • 2018 · 36 ✖

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0081-0039 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Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:24:05Z   0 0 09000064834dd07f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Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry Supporting & Related Material Background Material 2018-07-12T04:00:00Z 2018 7     2020-03-09T15:22:41Z   0 0 09000064834dd911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

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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);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;