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NORD Comments on PDUFA Draft

Every five years, the Prescription Drug User Fees Act (PDUFA) must be reauthorized.

Every five years, the Prescription Drug User Fees Act (PDUFA) must be reauthorized. This Act provides funding to FDA that has generally been believed to improve patient safety and the speed with which potential new drugs are reviewed.

NORD is meeting regularly with FDA officials and others in preparation for the reauthorization of PDUFA in 2012. Read statement of NORD's position submitted early on in the process to FDA.

FDA recently released a draft document summarizing its position to date on the PDUFA reauthorization.  NORD responded with a statement of support for the content related to rare diseases and orphan products on page 23 of the document.  Read the FDA draft and, in particular, the section on rare diseases on page 23.

 
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