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PDUFA V deal adds 60-day cushion for new drug, biologic reviews

This article was originally published in Scrip

Executive Summary

Under an agreement with the biopharmaceutical industry, the clock will not start ticking on the US FDA's reviews of applications for new molecule entities (NMEs) and innovator biologics until 60 calendar days after the agency receives a drug maker’s submission, regulators revealed on 1 September.

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