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 Can be withdrawn if benefit not confirmed.
Exemples
- Tumor response rate as surrogate
- CD4 count for HIV drugs
- Recent withdrawals for unconfirmed benefit
Le saviez-vous ?
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 Can be withdrawn if benefit not confirmed.