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Some OTC Switch Benefits Are Intangible, But Influential – CDER’s Ganley

This article was originally published in The Pink Sheet Daily

Executive Summary

Non-measurable benefits can tip the scales in the benefit-risk consideration of an OTC switch NDA, suggests Charles Ganley, director of CDER's Office of Drug Evaluation. One way to look at non-measurable benefits is OTC ingredients "lower the threshold” for patient “misery” prior to seeking relief, he says.


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