Report to the Nation 2004

This report of FDA’s Center for Drug Evaluation and Research (CDER) gives a really good overview on the activities and initiatives of FDA in the last year. Reviews: 119 new medicines were approved, including 36 truly new medicines that had not been marketed in any form before in the U.S., 147 new or expanded uses for already approved medicines and 380 generic versions of existing drugs. Drug safety: more than 400,000 reports of adverse drug events were processed and evaluated, including more than 20,000 submitted directly from individuals.