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

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.

If you have any questions about this Alert or would

like more information, please contact Frederick R. Ball, any of

the other health law lawyers in the Pharmaceutical &

Biotechnology industry group or the attorney in the firm with

whom you are regularly in contact.

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include full legal analysis of the matters presented. It should

not be construed or relied upon as legal advice or legal

opinion on any specific facts or circumstances. The description

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herein does not mean or suggest that similar results can or

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