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OTC Switches Face Tougher FDA Evaluations, Less Predictable Process

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

Executive Summary

OTC switch sponsors bear more responsibility than in previous years to convince FDA a product would be safely used and has a strong risk/benefit profile, say Pinney Associates consultants. FDA currently is more conservative on risk/benefit decisions and the advisory committee process isn't productive, they say.

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