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PDUFA reauthorization, FDA reform will not hold Congress in session -- FDA's Schultz.

This article was originally published in The Tan Sheet

Executive Summary

FDA REFORM/PDUFA REAUTHORIZATION WILL NOT KEEP CONGRESS IN SESSION following passage of the appropriations bills, FDA Deputy Commissioner for Policy William Schultz warned at a Sept. 3 Food & Drug Law Institute meeting in Washington DC. "Important as [the Prescription Drug User Fee Act] is, it is not going to hold Congress in session," Schultz maintained. "There is a very good chance that legislation will pass," Schultz said, "but unfortunately there is also a very real risk that it won't."

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