No Strings Attached

Peters, Rita C.
May 2012
Drug Discovery & Development;May2012, Vol. 15 Issue 5, p4
The author discusses the implications of the reauthorization of the Prescription Drug User Fee Act (PDUFA) in the U.S. She explains that the legislation must be renewed before its expiration date on September 30, 2012 because it may compromise the drug review process and may force the Food and Drug Administration (FDA) to lay off as many as 2,000 employees. She also cites a report of the Tufts Center on the mixed regulatory burden presented by PDUFA to drug sponsors.


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