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withdrawn,object_id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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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