'Progressive Approval' Coming? US FDA Considers Accelerated Approval Without Surrogates
Commissioner Gottlieb tells Congress that concept could be used for some clinical endpoints when a large benefit is seen in a small trial, which could benefit rare disease drug development.
You may also be interested in...
The data may be different, but US FDA will consider real-world evidence to add a tissue-agnostic indication, as well as take it away.
FDA’s decision to restrict use based on the level of PD-L1 expression shows how confirmatory trials for accelerated approval can help to inform and adapt labeling.
US FDA Commissioner says that with strong benefit shown, some risks can be discharged postmarket.