President Bush signs FDA amendment reauthorizing PDUFA


WASHINGTON The Food and Drug Administration’s Amendment Act, H.R. 3580 was signed into law by President Bush, reauthorizing the Prescription Drug User Fee Act and also granting the FDA more post marketing drug safety authority.

Signing the bill into law before PDUFA’s expiration date eliminates the possibility of significant reductions in the FDA’s workforce, FDA commissioner Andrew von Eschenbach said. Reauthorizing PDUFA also ensures “that our centers have the additional resources that are needed to conduct the very complex and comprehensive reviews of new drugs,” he added.

FDA deputy commissioner Janet Woodcock also discussed the agency’s creation of an electronic surveillance system for monitoring adverse events. Under the law, all clinical trials, including Phase I trials, would be required to register in a clinical trial registry shared between the National Institutes of Health and the FDA.

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