3 FDA’s Final Guidance Docs for Individual Patient Expanded Access - What should You Know?
Times when patients are going through serious / immediately life-threatening conditions and physicians are left with no options except to opt for the investigational treatments, navigating certain processes would be challenging and time-consuming. Reducing those procedural burdens to streamline the processes and in order to provide the physicians the flexibility to access investigational drugs and biologics, the US Food and Drug Administration (US FDA), on June 2, 2016 has released 3 final guidance documents.