Pharmacy Times: Review of 3 Alternative Pathways to Access Non–FDA-Approved Drugs
Recently, the FDA has taken additional actions to clarify and streamline its policies regarding the EA process, including issuing guidance documents on EA, restructuring the FDA web page on EA, launching Project Facilitate (a call and information center to help with EA request submissions), simplifying the application form for single-patient requests so that form completion takes an estimated 45 minutes, and working with the Reagan-Udall Foundation to launch the Expanded Access Navigator website to help patients and physicians more easily locate relevant information about EA.