FDA Issues Guidance on Endpoints for Cancer Clinical Trials

December 20, 2018 – This week, the U.S. Food and Drug Administration (FDA) issued a guidance titled Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics. The guidance provides recommendations to applicants on endpoints for cancer clinical trials submitted to the FDA to support effectiveness claims in applications. This updated guidance will help advance the efficient development of cancer drugs and biologics. The guidance is a … (leggi tutto)