CDER Benefit/Risk Assessment Tool Has Room For OTC Considerations
This article was originally published in The Tan Sheet
Executive Summary
A new benefit/risk framework for drug reviews currently being tested in FDA requires incremental considerations to apply to OTC reviews, a CDER official says. Former NDAC chairman Brass says FDA’s model is compatible with a separate OTC assessment framework developed for industry.
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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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