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ARTICLE | Regulation

New surrogate endpoints need resolution of ‘reasonably likely’ 

Regulatory clarity, consistency, key to taking accelerated approval outside of cancer

August 31, 2021 1:00 PM UTC

If accelerated approval is to gain widespread adoption outside of cancer in the U.S., there will need to be a reckoning of the evidentiary requirements to meet FDA’s “reasonably likely” standard.

Drug developers want more guidance, predictability and clarity around acceptance of surrogate endpoints. They are seeking guidelines around how likely a surrogate endpoint must be to predict clinical benefit, as well as the size of that benefit...



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