By David Michaels It is starting to feel like a groundswell. Last week, a group of 22 experts on drug safety and regulation issued an open letter to lawmakers asking Congress not to reauthorize the Prescription Drug User Fee Act (PDUFA), the system that funds the Food and Drug Administrationâs drug review process. In that […]
By David Michaels In the wake of the debacles involving Vioxx, Ketek, and other dangerous drugs that should never have been approved in the first place, Congress is about to take up reauthorization of the user fee system that funds the Food and Drug Administrationâs drug review process. The system is governed by the Prescription […]