FDA’s Benefit/Risk Framework Turns 10: A Quietly Critical Innovation
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.
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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.
Drug reviews will include a benefit-risk summary assessment that states the rationale for regulatory action on a drug or biologic application and explains how differences of opinion among reviewers were resolved.
Overall survival is the only viable endpoint for pragmatic trials in oncology, the US FDA and a panel of stakeholders agree, although other novel endpoints could be validated over time. In the meantime, FDA says, sponsors should focus on other aspects of trials that can be streamlined.