Safety Questions Remain for Expedited FDA Drug Approvals
(Ivanhoe Newswire) –Fewer patients were studied as part of expedited reviews of new drugs approved by the FDA in 2008 and safety questions remain unanswered, according to a recent study.
In 2008, the FDA approved 20 therapeutic drugs (eight under expedited review and 12 under standard review). Thomas J. Moore, A.B., of the Institute for Safe Medication Practices, Alexandria, Va., and Curt D. Furberg, MD, PhD, of the Wake Forest School of Medicine, Winston-Salem, N.C., examined development times, clinical testing, post-market follow-up and safety risks for the 20 drugs approved by the FDA in 2008, when most provisions of current law, regulation, and policies were in effect.
Researchers discovered that expedited drugs took a median of 5.1 years of clinical development to get marketing approval compared with 7.5 years for the drugs that underwent standard review.
For more information, go to: http://media.jamanetwork.com/news-item/study-examines-expedited-fda-drug-approvals-safety-questions-remain/
SOURCE: JAMA Internal Medicine, October 2013
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