FDA to launch program to facilitate expanded access at ASCO meeting

FDA will announce at the upcoming ASCO meeting the launch of Project Facilitate, a concierge service to help guide physicians through the process of applying for expanded access, also called compassionate use access.

Speaking Thursday at a meeting about Project Facilitate, Acting FDA Commissioner Ned Sharpless said he hopes it creates more transparency around expanded access and encourages manufacturers to provide access to investigational therapies. ...