What Innovation Crisis? First-In-Class Drug Approvals Stable For Almost 25 Years, FDA Says
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
An FDA study evaluating NMEs by level of innovation finds level first-in-class approvals to be consistent, and approvals after the study period reinforce “encouraging” findings. Analysis says new metric should be basis for assessment of programs created by FDASIA to speed development of innovative products.
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