FDA Announces a Single Pivotal Trial as the New Default Standard for All Drug Approvals and Unveils a Plausible Mechanism Framework for Individualized Therapies

On February 18, 2026, U.S. Food and Drug Administration (FDA) Commissioner Martin Makary and the outgoing director of the Center for Biologics Evaluation and Research (CBER) Vinay Prasad published an article in The New England Journal of Medicine, in which they announced FDA’s new default position to require only a single pivotal trial for all drug approvals instead of the current default standard requiring two trials. A few days later, on February 23, 2026, FDA marked Rare Disease Week by... By: Troutman Pepper Locke