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Drug safety regulation and the Prescription Drug User Fee Act

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The Washington, D.C., chapter heard a lively and informative panel discussion on the reauthorization of the Prescription Drug User Fee Act (PDUFA) on July 18, 2007. Audio of the panel is available for download.

PDUFA, which has been passed in different forms in the House and the Senate, is currently in a Congressional conference committee. The law regulates how the Food and Drug Administration pays for reviews of new drug applications and addresses drug safety issues such as post-marketing reviews of new drugs and reviewing direct-to-consumer drug advertisements.

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