Drug makers have yet to begin more than two out of every three pending studies that they promised to conduct after their products were approved by U.S. regulators.
February 2nd, 2007The Food and Drug Administration determined that 899 of 1,259 post-approval studies hadn’t been started as of Sept. 30, according to data posted Thursday on the agency’s Website. The numbers do not include completed studies.
To receive FDA approval, drug makers often agree to perform additional studies of safety, dosing and other matters after medications come to market. Doctors say post-approval studies may be needed to fully assess the risks of medications because some dangers don’t emerge until products are in widespread use.
Members of Congress have criticized the FDA’s oversight of drug safety in recent years, as studies linked antidepressants to suicide risk for children and painkillers to elevated chances of heart attacks. Merck & Co. withdrew its Vioxx painkiller in 2004 after a company study showed higher heart attack and stroke risks.
Become one of the Thousands Who Have Now Discovered Insurance Company Secrets, even though they Never Thought They Could. We will pay for the shipping
Or, to learn more about What Everybody Should Know… About How To Discover Insurance Company Secrets-click here
FDA Oversight
FDA oversight has come under criticism, espeically in a post-Vioxx world….