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Intangible Benefits Are Influential In OTC Switch Decisions – CDER’s Ganley

This article was originally published in The Tan Sheet & The Rose Sheet

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 IV. One way to look at non-measurable benefits is how OTC ingredients "lower the threshold” for patient “misery” prior to seeking relief, he says.


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