US FDA's Benefit/Risk Framework Gets High Marks But Could Be Improved
Agency summaries contained in reviews of novel drugs and biologics are useful and informative but difficult to find, and their use should be expanded to other types of applications, industry sponsors and other external stakeholders say.
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A core group of big pharma companies has been pressing FDA for over a decade to adopt a quantitative formula for conducting and communicating benefit-risk decisions. FDA has changed its benefit-risk calculations in response – but not its basic way of doing the math.
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Structured assessments, which are currently publicly available only for approved products, could help frame questions for panel discussion of specific drugs under review; FDA also exploring ways to make completed frameworks more readily accessible.