FDA Post-Approval Studies Lack Transparency, Consistent Enforcement, According to Researchers – Healio

Read article - Quotes Steven Woloshin, professor of medicine, community and family medicine, and of the Dartmouth Institute for Health Policy and Clinical Practice, about a study he conducted that found more than half of the post-approval studies required by the FDA in 2009 and 2010 were either delayed or had not yet started as of 2015. "Unfortunately, we do not have any example of where the FDA has actually imposed a fine or rescinded approval," says Woloshin. "We know that there have been a few warning letters written to companies that haven't fulfilled their requirements, but the FDA, as far as we can tell, has never actually imposed a fine or revoked approval for a drug because the post-marketing studies have not been completed."