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BioPharmaceutical United States Drug Approval Standards

“Breakthrough Therapies” Deserve Skepticism, Researchers Say

This article was originally published in The Pink Sheet Daily

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Executive Summary

Although drugs on the FDASIA-created expedited pathway may promise more than they can deliver, it will be difficult to reduce demand for such treatments awarded the designation, Boston researchers predict in a NEJM piece.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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