FDA’s Project Facilitate fielded 161 compassionate use requests in first three months

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Project Facilitate, an FDA call center that guides physicians through the process of obtaining expanded access — or compassionate use — to investigational cancer therapies, handled about 161 requests from its launch on June 3 to Aug. 31, an agency spokesperson told BioCentury.

Project Facilitate has had a 20% increase in single-patient IND submissions compared with the same period last year, according to the spokesperson.

FDA authorized all of the requests submitted through Project Facilitate, but it does not know how many of them were approved by drug manufacturers, the spokesperson said.

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