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BioPharmaceutical United States Drug Approval Standards

Buying Time: Industry Sacrifices Early To Gain Later With PDUFA V Review Model

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Executive Summary

NMEs and novel biologics will see reviews allotted two additional months under the revised model launching Oct. 1. Industry expects to gain more communication and first-cycle approvals, while FDA hopes it can receive more complete applications at submission and improve transparency.

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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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