See at
http://www.bmj.com/content/360/bmj.k294.full?ijkey=iXO174VuvPHfk&keytype=ref&siteid=bmjjournalsDescription
Article discussing the announcement by the FDA on January 16, 2018 of the decision to disclose clinical study reports (CSRs) in a pilot program. Also included is a comparison of the US regulatory agency’s practices with those of its European counterpart, the European Medicines Agency (EMA)Citation
Doshi, P. (2018). News: FDA to begin releasing clinical study reports in pilot programme. BMJ, 360:k294. DOI: 10.1136/bmj.k294Keyword
clinical study reportsEMA
FDA
Drug Industry
European Medicines Agency
United States. Food and Drug Administration