President Obama Signs the 21st Century Cures Act, Accelerating Review of Drugs and Medical Devices
Yesterday afternoon, President Obama signed the 21st Century Cures Act into law. The Act, passed by overwhelming bi-partisan margins in both the House and Senate contains provisions on diverse topics, including the Beau Biden Cancer Moonshot, funding for mental health and substance abuse programs, and reauthorizing the National Institutes of Health (NIH). This memo does not attempt an exhaustive summary of the legislation. Instead, it highlights certain provisions related to accelerated Food and Drug Administration (FDA) review, changes to clinical trial design, expanded access for patients to drugs and devices, and increased data sharing among researchers.