Study examines quality of evidence for drugs granted accelerated FDA approval

(The JAMA Network Journals) Among drugs granted accelerated approval by the FDA in 2009-2013, efficacy was often confirmed in subsequent trials a minimum of three years after approval, and the use of nonrandomized studies and surrogate measures, instead of clinical outcomes, was common, according to a study published by JAMA.

from EurekAlert! - Social and Behavioral Science http://ift.tt/2vAyRef