March 7, 2017, Vol 317, No. 9, Pages 883-984
The European Medicines Agency and Publication of Clinical Study ReportsA Challenge for the US FDA
Anna L. Davis, JD, MPH; James Dabney Miller, JD, MPH
JAMA. 2017;317(9):905-906. doi:10.1001/jama.2017.0918
This Viewpoint argues that publication by the European Medicines Agency of clinical study reports as part of its approval process for commercial drugs sets a standard of transparency that could challenge the reputation of the US Food and Drug Administration as the international standard-bearer in drug and device approval.