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