Accelerated Approval

Regulatory

FDA pathway allowing approval based on surrogate endpoints reasonably likely to predict clinical benefit. Requires post-marketing confirmatory trials. Can be withdrawn if benefit not confirmed.

Ví dụ

Tumor response rate as surrogate
CD4 count for HIV drugs
Recent withdrawals for unconfirmed benefit

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FDA pathway allowing approval based on surrogate endpoints reasonably likely to predict clinical benefit. Requires post-marketing confirmatory trials. Can be withdrawn if benefit not confirmed.