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Efficacy Differences Within Drug Classes Unsupported By Data, FDA's Temple Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Studies that look for differences in efficacy among members of the same drug class are only performed when necessary for approval, CDER Office of Medical Policy Director Temple tells DIA. While questioning the introduction of "follow-on" compounds, Temple also highlights AstraZeneca's success in achieving a more optimal dose for Nexium.

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