FDA's acting commissioner has an opportunity to clarify a lot of misconceptions about the agency's role in regulating drug safety. His first order of business should be to explain exactly what FDA doesn't do. Jan 1, 2006 By:Kenneth I. Kaitin
Often, post-approval marketing studies don't materialize because drug companies question their value. Independent review of the need for such studies would address pharma's concern that they may be warranted.