Role of CTSA institutes and academic medical centers in facilitating preapproval access to investigational agents and devices during the COVID-19 pandemic.
Misty GravelinJeanne WrightM E Blair HolbeinMarlene BerroJennifer Swanton BrownGeorge A MashourKevin J WeatherwaxPublished in: Journal of clinical and translational science (2021)
AMC- and CTSA-based regulatory units played a meaningful role in the COVID-19 pandemic but further unit modifications are needed for enabling more robust regulatory support in the future.