FDA's Expedited Approval of Drugs is Based on Trials of 104 Patients vs. 580 Patients for Non-Expedited Approvals

According to a study published by JAMA Internal Medicine, 80% fewer patients were studied as part of expedited reviews of new drugs approved by the U.S. Food and Drug Administration (FDA). Not only that, but many of the required postmarketing studies of these drugs were not completed after 4 years! Here's the relevant section of the press release: Thomas J. Moore, A.B., of the Institute for Safe Medication Practices, Alexandria, Va., and Curt D. Furberg, M.D., Ph.D., 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 new drugs approved by the FDA in 2008, when most provisions of current law, regulation and policies were in effect.Read more ยป
Source: Pharma Marketing Blog - Category: Pharma Commentators Tags: Drug Approval Drug Safety FDA trust Source Type: blogs