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

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16 rows where docket_id = "FDA-2015-P-2820" and posted_year = 2016 sorted by posted_date descending

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  • 2016 · 16 ✖

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2015-P-2820-0070 FDA None FDA-2015-P-2820 Exhibit 21 Lougheed, K. Hepatitis C drug trial halted after patient death August 24, 2012 re: Amendment from Center for Responsible Science Supporting & Related Material Background Material 2016-03-21T04:00:00Z 2016 3     2016-03-21T16:24:31Z   0 0 0900006481ecf1a7
FDA-2015-P-2820-0066 FDA None FDA-2015-P-2820 Exhibit 13 Brennan EMA Will Assess ANSM Review of Botched Clinical Trial in France, January 19, 2016 re: Amendment from Center for Responsible Science Supporting & Related Material Background Material 2016-03-21T04:00:00Z 2016 3     2016-03-21T15:03:55Z   0 0 0900006481ecf19f
FDA-2015-P-2820-0067 FDA None FDA-2015-P-2820 Exhibit 14 Attarwala, H. TGN1412; From Discovery to Disaster re: Amendment from Center for Responsible Science Supporting & Related Material Background Material 2016-03-21T04:00:00Z 2016 3     2016-03-21T15:15:59Z   0 0 0900006481ecf1a0
FDA-2015-P-2820-0071 FDA None FDA-2015-P-2820 Exhibit 22 O'Riordan, M. After Patient's Death, Study Shows HCV Drug Cardiotoxic in 14 of 34 Treated Patients Source: www.medscape.com/viewarticle/832251_print September 24, 2014 re: Amendment from Center for Responsible Science Supporting & Related Material Background Material 2016-03-21T04:00:00Z 2016 3     2016-03-21T16:31:17Z   0 0 0900006481ed3d8d
FDA-2015-P-2820-0064 FDA None FDA-2015-P-2820 Exhibit 11 The Pharmaletter, ANSM continues investigations into Bial clinical trial death, March 10, 2016 re: Amendment from Center for Responsible Science Supporting & Related Material Background Material 2016-03-21T04:00:00Z 2016 3     2016-03-21T14:51:57Z   0 0 0900006481ecf19d
FDA-2015-P-2820-0065 FDA None FDA-2015-P-2820 Exhibit 12 Minutes of the Temporary Specialist Scientific Committee (TSSC) meeting on "FAAH (Fatty Add Amide Hydrolase) Inhibitors" of 15 February 2016. re: Amendment from Center for Responsible Science Supporting & Related Material Background Material 2016-03-21T04:00:00Z 2016 3     2016-03-21T14:58:22Z   0 0 0900006481ecf19e
FDA-2015-P-2820-0069 FDA None FDA-2015-P-2820 Exhibit 20 Lerman, R. FDA halts trial of cancer drug by Seattle's CTI BioPharma after patients die, Source http://www.seattletimes.com/business/fda-halts-cti-biopharma-drug-trial-for-detrimental-effect-on-survival/ February 10, 2016 re: Amendment from Center for Responsible Science Supporting & Related Material Background Material 2016-03-21T04:00:00Z 2016 3     2016-03-21T16:08:23Z   0 0 0900006481ecf1a6
FDA-2015-P-2820-0062 FDA None FDA-2015-P-2820 Exhibit 8 Business Insider, Feb 5, 2016 Authorities are rapping up their investigation of a deadly drug trial that left one dead and several others in hospital re: Amendment from Center for Responsible Science Supporting & Related Material Background Material 2016-03-21T04:00:00Z 2016 3     2016-03-21T14:31:05Z   0 0 0900006481ecf19a
FDA-2015-P-2820-0063 FDA None FDA-2015-P-2820 Exhibit 9 The Guardian Man who died in French drug trial had 'unprecedented' reaction, say experts. March 2016 re: Amendment from Center for Responsible Science Supporting & Related Material Background Material 2016-03-21T04:00:00Z 2016 3     2016-03-21T14:39:36Z   0 0 0900006481ecf19b
FDA-2015-P-2820-0068 FDA None FDA-2015-P-2820 Exhibit 16 Scientific Bloggging Science 2.0 Blood Test Predicts Cytokine Storm Drug Reaction In Humans March 9, 2015 re: Amendment from Center for Responsible Science Supporting & Related Material Background Material 2016-03-21T04:00:00Z 2016 3     2016-03-21T15:29:46Z   0 0 0900006481ecf1a2
FDA-2015-P-2820-0059 FDA None FDA-2015-P-2820 Exhibit 1 Advancing Regulatory Science at FDA August 2011 re: Amendment from Center for Responsible Science Supporting & Related Material Background Material 2016-03-18T04:00:00Z 2016 3     2016-03-18T16:55:18Z   0 0 0900006481ecf142
FDA-2015-P-2820-0058 FDA None FDA-2015-P-2820 Amendment from Center for Responsible Science (CRS) Other Amendment 2016-03-18T04:00:00Z 2016 3 2016-03-18T04:00:00Z   2016-03-18T16:50:12Z   0 0 0900006481eceacd
FDA-2015-P-2820-0061 FDA None FDA-2015-P-2820 Exhibit 7 Online News Articles from Different Organizations re: Amendment from Center for Responsible Science Supporting & Related Material Background Material 2016-03-18T04:00:00Z 2016 3     2016-03-18T17:14:44Z   0 0 0900006481ecf199
FDA-2015-P-2820-0060 FDA None FDA-2015-P-2820 Exhibit 2 Baker et al How Regulatory Updates Allowing for More Modern Test Methods, Pragmatic Validation of Preclinical Test Methods, and FDA Guidances Will Lead to Advancement of More Predictive Preclinical Testing Tools, Efficiency, and Safer and More Effective Drugs FDLI Food and Drug Policy Forum re: Amendment from Center for Responsible Science Supporting & Related Material Background Material 2016-03-18T04:00:00Z 2016 3     2016-03-18T16:59:37Z   0 0 0900006481ecf143
FDA-2015-P-2820-0057 FDA None FDA-2015-P-2820 Interim Response from FDA CDRH to Alston & Bird, LLP Other Letter(s) 2016-03-14T04:00:00Z 2016 3 2016-03-14T04:00:00Z   2016-03-14T13:56:23Z   0 0 0900006481ebff6f
FDA-2015-P-2820-0056 FDA None FDA-2015-P-2820 Status Inquiry re Requests that the FDA modify existing regulations in Title 21 of the Code of Federal Regulations (CFR) that govern requirements for investigational new drug (IND) applications, investigational device exemptions (IDE), and new drug applications (NDAs). Supporting & Related Material Background Material 2016-03-09T05:00:00Z 2016 3     2016-03-09T17:21:15Z   0 0 0900006481eb5c8b

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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;