Legal Minute: Decoding the FDA's prescription drug use related software guidance

FDA Issues Crucial Guidance on Prescription Drug Software! Darshan Kulkarni delves into the FDA's recent guidance on prescription drug-related software. The discussion revolves around three key considerations: 1. software functions, 2. end-user output, and 3. regulatory guidelines. Notably, the FDA emphasizes distinguishing between functions relying on direct device data transfer and those that don't. The document also outlines the significance of characterizing soft...