Alerts and Updates

FDA Announces Draft Prescription Drug User Fee Act for Drug Safety Five-Year Plan

May 6, 2008

On May 5, 2008, the FDA published for public comment a draft drug safety five-year plan entitled "Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan." Through the plan, the FDA is communicating its strategy for meeting commitments the FDA made to Congress for enhancing and modernizing the drug safety system within the context of PDUFA IV. Written or electronic comments are due at the FDA no later than June 19, 2008.

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