Risk/Benefit Value Tool Could Trim Guesswork From OTC Switch Attempts
This article was originally published in The Tan Sheet
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CDER Benefit/Risk Assessment Tool Has Room For OTC Considerations
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.
CDER Benefit/Risk Assessment Tool Has Room For OTC Considerations
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.
OTC Switch “Blueprint” Could Help Regulatory Navigation – Researchers
Rx-to-OTC switch questions that FDA asked advisory committees over the past 10 years can help guide future sponsors to success, says the lead researcher in an analysis of the agency’s switch actions.