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Washington Roundup

BIO, PhRMA Press Forward on PDUFA with Industry Database

By Mari Serebrov
Washington Editor

Tuesday, June 25, 2013
Although PDUFA V has been in effect for just nine months, the biopharma industry already is setting up the ironing board for the next round of user fee negotiations with the FDA. The Biotechnology Industry Organization and Pharmaceutical Research and Manufacturers of America have teamed up to create a database that will detail industry's side of PDUFA by tracking sponsors' experiences throughout the review process for new drugs and biologics.

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