Melissa Tearney, Emily Hodge and Sara Frank on the FDA Expanded Access Program

View “Expanded Access-A Regulatory Balancing Act For Drug Cost."

Melissa Tearney, Emily Hodge and Sara Frank wrote “Expanded Access-A Regulatory Balancing Act For Drug Cost,” in White Collar Law360, where they discuss how the FDA provides regulations, oversight and guidance to companies over experimental drugs. However, many of the toughest questions are left for manufacturers to resolve on their own as they assess how to grant patients access to an experimental drug in a safe, fair and ethical manner outside the context of a clinical trial.