We are dedicated to creating thought-leading forums to share and connect. Watch one of our webcasts to gain insights on the industry’s hottest topics.
** See note about FDA Accelerated Approval at the bottom of this page.
**Accelerated Approval is a type of FDA expedited review pathway. It allows for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint that is reasonably likely to predict clinical outcomes. A surrogate endpoint is a marker that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. Subsequent confirmatory trials to confirm the clinical benefit must be conducted to support traditional full approval.