Expanded Access Updates (U.S.) Jul 19, 2016

JAMA Network

Recently completed efforts to streamline the “compassionate use” process physicians use to obtain investigational drugs and biologics for their patients include a shortened request form and new support documents.

Physicians can use the Individual Patient Expanded Access Investigational New Drug Application—Form FDA 3926—to request expanded access to investigational drugs when patients with serious or immediately life-threatening diseases have no comparable or satisfactory alternative therapy. It should take about 45 minutes to complete the new form, according to the FDA. Along with the new form, the agency has released step-by-step instructions on how to complete it.