Lawyer: Key Questions Linger With FDA’s New Drug Software Framework

FDA Commissioner Scott Gottlieb on Monday (Nov. 19) introduced a new risk-based framework for how the agency will regulate software products that are designed to be used in conjunction with prescription drugs, also known as prescription drug-use-related software. However, while one medical device and pharmaceutical industry lawyer says the new framework is a great start, he argues it fails to clearly answer industry’s main question: What kinds of drug-related software will be regulated as devices. The goal of the framework,...