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Note to Correspondents

FOR IMMEDIATE RELEASE
November 11, 2005

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

PDUFA White Paper Available

FDA today posted onto its Web site a White Paper entitled "Prescription Drug User Fee Act (PDUFA):

Adding Resources and Improving Performance in FDA Review of New Drug Applications.

" The White Paper follows a press release issued yesterday entitled, "FDA Seeks Public Input on Renewal Process for Prescription Drug User Fee Act (PDUFA)." The press release can be found on FDA's Web site at http://www.fda.gov/bbs/topics/news/2005/NEW01259.html.

The White Paper can be found at: http://www.fda.gov/oc/pdufa/PDUFAWhitePaper.pdf.

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