FDA to Launch Expanded Access Pilot ‘Project Facilitate’

The goal of Project Facilitate is to make it easier for oncologists or healthcare providers without the regulatory experience or resources to navigate the single patient IND process.

“Access to clinical trials and access to novel therapeutics for patients is still a problem. We know that not all oncologists or healthcare providers have the regulatory expertise or resources to navigate the single patient [investigational new drug] IND process, and I know many oncologists just assume the process is cumbersome without even trying it,” said Acting FDA Commissioner Ned Sharpless.

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