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.
For Further Information
If you have any questions about this Alert or would like more information, please contact Frederick R. Ball, any of the other lawyers in the Pharmaceutical & Biotechnology industry group or the attorney in the firm with whom you are regularly in contact.
Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.