FDA Launches Expanded Access Pilot ‘Project Facilitate’ - Regulatory Focus

The US Food and Drug Administration (FDA) on Monday launched a new pilot program, dubbed Project Facilitate, aimed at helping physicians complete expanded access requests for cancer patients.
“The FDA has been working diligently to improve the Expanded Access framework, including development of an updated and more streamlined application form, but despite recent improvements, we understand that for many patients or health care professionals, especially those not familiar with the Expanded Access program, the process may appear confusing or burdensome,” said Acting FDA Commissioner Ned Sharpless.

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