Which statement describes accelerated approval endpoints?

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Multiple Choice

Which statement describes accelerated approval endpoints?

Accelerated approval relies on endpoints that are surrogate or intermediate measures likely to predict a real clinical benefit, so patients gain access sooner for serious diseases with unmet needs. This pathway requires post-approval confirmatory trials to verify that the benefit actually occurs. If these trials confirm benefit, the approval stands; if not, the FDA can withdraw approval or require changes. The other descriptions don’t fit: full clinical endpoints and mild conditions aren’t the basis for accelerated approval, there are post-approval requirements, and the pathway isn’t limited to vaccines.

Accelerated approval relies on endpoints that are surrogate or intermediate measures likely to predict a real clinical benefit, so patients gain access sooner for serious diseases with unmet needs. This pathway requires post-approval confirmatory trials to verify that the benefit actually occurs. If these trials confirm benefit, the approval stands; if not, the FDA can withdraw approval or require changes. The other descriptions don’t fit: full clinical endpoints and mild conditions aren’t the basis for accelerated approval, there are post-approval requirements, and the pathway isn’t limited to vaccines.

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