Accelerated drugs approval evaluated
European Pharmaceutical Review | August 16, 2017
Researchers have evaluated the features of pre-approval and post-approval clinical trials of drugs granted Accelerated Approval by the U.S Food and Drugs Administration (FDA). To understand how this pathway is implemented, researchers examined the pre-approval and post-approval clinical trials of drugs granted approval between 2009 and 2013. During that time, the FDA granted 22 drugs and ordered 38 post-approval studies to confirm the safety and efficacy of these drugs.