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PDUFA public meeting

This article was originally published in The Tan Sheet

Executive Summary

FDA will host a public meeting to gather stakeholder feedback on the Prescription Drug User Fee Act (PDUFA) Nov. 14 from 9 a.m. to 5 p.m. The agency requests that the public consider two questions in preparation for the meeting or submitted comments: "What is your assessment of the overall performance of the PDUFA programs thus far?" and "What aspects of PDUFA should be retained, or what should be changed to further strengthen and improve the program?" Current PDUFA legislation will expire in September 2007. Those planning to attend the meeting must be registered by Oct. 31 and written comments must be submitted by Dec. 14, FDA states...

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