FDA's standards for applying accelerated approval should not be "totally wide open," but also should not set a bright line for access to the expedited approval pathway, Commissioner Robert Califf said.
One of the unknowns with the use of accelerated approval is what amount of data constitutes "reasonably likely" to predict clinical benefit. It typically involves an effect on a biomarker...
Statutes and regulations leave that standard to FDA's judgment, meaning there may not always be agreement on how it should be applied.