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Accelerated Approvals Could Be Improved By Focusing On Benefit/Risk, Making Withdrawal Easier

 
• By Sue Sutter

Applying the expedited pathway in the context of a preliminary benefit/risk assessment, rather than focusing solely on predictive surrogate or intermediate clinical endpoints, would give the US FDA more flexibility, Friends of Cancer Research working group says in a new white paper.

the waiter cleaning the table in a outdoor cafe. He collects dirty dishes in a tray.
Giving US FDA the ability to easily clear the table of an accelerated approval drug that fails to confirm clinical benefit is proposed in a new white paper. • Source: Shutterstock

The US Food and Drug Administration’s accelerated approval program could be improved by reframing its focus on a drug’s benefit/risk profile rather than the effect on a surrogate endpoint.

Consideration also should be given to having sponsors resubmit for continued approval, rather than putting the onus on the FDA...

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