PDUFA

Category archives for PDUFA

Friday Blog Roundup

The FDA certainly wasn’t the biggest newsmaker this week, but it did create some buzz in the blogosphere – mostly due to the Prescription Drug User Fee Act, or PDUFA, which is up for Congressional reauthorization. Matt Madia at Reg Watch and Merrill Goozner at GoozNews are tracking PDUFA’s progress through the Senate. Corpus Callosum…

By Susan Wood Next week both the Senate and House are moving forward on legislation to reauthorize the Prescription Drug User Fee Act (PDUFA), along with other key FDA legislation.  The Senate will be “marking up” a large omnibus piece of legislation that combines PDUFA with drug safety legislation, pediatric legislation, and medical device legislation. …

Breaking FDA’s User Fee Habit (2)

By David Michaels The Prescription Drug User Fee Act (PDUFA), through which the FDA collects money from drug makers in exchange for faster reviews of their new products, gets skewered again – this time in a piece by Christopher Moraff in the American Prospect Online. (We’ve been covering the issue here at TPH; more materials…

Breaking FDA’s User Fee Habit

By David Michaels The campaign by policy experts to have Congress end the user fee system that funds FDA is picking up steam. The Prescription Drug User Fee Act (PDUFA) allows FDA to collect money from drug makers in exchange for faster reviews of their new products. But PDUFA makes the FDA dependent on the…

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 Administration’s 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 Administration’s drug review process. The system is governed by the Prescription…