US FDA Exploring Options To Improve Study Of Drugs In Elderly
New incentives will most likely not be the immediate focus, but working group to explore ideas on enhancing understanding of drug effects in elderly populations will likely be formed by US FDA.
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US FDA is open to keeping COVID-necessitated trial changes that may have had unexpected benefits. The agency is also looking at building on pandemic’s focus on health disparities and inequities to push for more generalizable and inclusive clinical trial designs.
Medicare patients fared worse than pivotal trial populations on cancer drugs, two recent papers conclude, offering more ammunition for an increased regulatory focus on more generalizable trial populations. Current drug labels may portray an inaccurate risk-benefit calculation in older populations, which account for most cancer cases.
FDA principal deputy commissioner Amy Abernethy and former commissioner Robert Califf point to success of orphan drug and pediatric exclusivity incentives in spurring drug development for neglected populations.