Gastroenterology-Urology Devices Panel

FDA panel recommends device approval but questions sponsor’s clinical trial change

The U.S. Food and Drug Administration (FDA) allows for some flexibility related to changes in clinical trial protocols—for example, with adaptive trials. However, as one sponsor has found out, certain changes can lead to some pointed questions from agency officials. TransMedics Inc., an Andover, Mass.-based device company, is waiting for a decision from the FDA […]