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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In finalizing a guidance on its approach to the fundamental benefit-risk assessment for new drug reviews, US FDA affirms the central role of the qualitative benefit-risk framework tool that was rolled out a decade ago.
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.
US FDA seeks White House approval for to contract for interviews with 100 to 150 active commercial IND holders.