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OTC Switches Face Tougher FDA Evaluations, Less Predictable Process

 
• By Eileen Francis

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.

Facing a more conservative FDA, a less predictable advisory committee process and “evolving” standards for evaluating Rx-to-OTC switches, drug firms have to do more and better work than previously to demonstrate their proposed switches' public health benefits, say drug application consultants.

“The current group at FDA seems a bit more conservative than groups in the past and in particular, more concerned...

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