Current Edition

Planning for Early Access Programmes

Early access programmes are becoming more common and more sophisticated, requiring greater attention and resources from sponsors. The FDA’s pilot programme is designed to help physicians as they seek access to unapproved, yet promising oncology medications for individual patients who have a poor prognosis and few treatment alternatives. Noolie Gregory at Syneos Health explores the US Food and Drug Administration’s (FDA’s) new pilot programme, Project Facilitate.