ARTICLE | Regulation
Stretching accelerated approval
Why FDA wants to make overall survival an endpoint for accelerated approval
March 12, 2018 6:02 PM UTC
FDA wants to stretch its accelerated approval pathway beyond traditional surrogate endpoints to include overall survival that has been demonstrated in small trials, such as exploratory studies.
The change is a response to advances in targeted drug development that are making it increasingly possible to identify potential breakthroughs early in clinical development. ...