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FDASIA: The Perfect Name for PDUFA V

This article was originally published in RPM Report

Executive Summary

The House and Senate negotiators picked the perfect acronym for the newest version of the Prescription Drug User Fee Act: FDASIA – as in FDA/Asia with a dose of Fantasia. On the safety side, the law will help FDA adapt to a global supply chain and especially the rise of China and India. As for accelerating drug development, the fantasy may outpace the reality.

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