Accelerated Approval
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 Can be withdrawn if benefit not confirmed.
Примеры
- Tumor response rate as surrogate
- CD4 count for HIV drugs
- Recent withdrawals for unconfirmed benefit
Знаете ли вы?
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 Can be withdrawn if benefit not confirmed.