Study examines expedited FDA drug approvals, safety questions remain
-The expedited drugs were tested for efficacy in a median 104 patients compared with a median 580 patients for standard review. By 2013, many postmarketing studies to gather additional evidence on the safety of expedited drugs had not been completed, according to researchers.
AMA Intern Med. Published online October 28, 2013. doi:10.1001/jamainternmed.2013.11813
– http://healthresearchreport.me/2013/11/01/study-examines-expedited-fda-drug-approvals-safety-questions-remain-avg-drug-is-tested-on-only-104-patients-prior-to-approval/