The resigning of the PDUFA was the fifth reauthorization. This is an achievement for patients, industry and the FDA. The PDUFA program will make certain that all Americans receive timely access to safe, effective, and affordable generic drugs. PDUFA is considered a must-pass measure because the FDA has become reliant on the money it generates. In 2010, more than $550 million in user fees collected by the FDA covered 62% of the agency’s costs for drug reviews.
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