Agency Releases First Public Clinical Study Report

FDA on Monday (March 19) released the first public clinical study report as part of a pilot program announced in January aimed at providing more transparency around FDA approval decisions. The report, which is more than 1000 pages, pertains to Janssen Biotech’s Erleada, which was approved Feb. 14 to treat non-metastatic, castration-resistant prostate cancer. FDA Commissioner Scott Gottlieb earlier this year announced the agency’s plan to release up to nine clinical study reports , which are “detailed summaries of the...