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OTC Switches Face Tougher FDA Evaluations, Less Predictable Process

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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For Successful OTC Switch Proposals, A Good Offense Defends Against Doubters

OTC switch sponsors should identify adversaries early in the application switch process so they can counter arguments that could derail their switch, s consultant advises. Some switches fail because firms target regulatory approval and do little on marketplace performance.

For Successful OTC Switch Proposals, A Good Offense Defends Against Doubters

OTC switch sponsors should identify adversaries early in the application switch process so they can counter arguments that could derail their switch, s consultant advises. Some switches fail because firms target regulatory approval and do little on marketplace performance.

OTC Switch Interest Cooled By Study Costs To Update Safety Data

Firms often are hesitant to prepare Rx-to-OTC switch applications because safety and efficacy data for their products are over a decade old, notes health care consultant Laura Mahecha.

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