3:33 PM
May 16, 2019
 |  BC Extra  |  Politics & Policy

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.

Project Facilitate will start as a pilot program focused exclusively on oncology products and may be expanded to include other therapeutic classes in the future.

FDA will provide a single telephone number that physicians can call to receive help completing paperwork required to apply for a single patient...

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