FDA Issues Guidance on Prescription Drug Apps
The US FDA issued new guidance to clarify how drug companies develop and label apps used with prescription medicines. The policy aims to reduce regulatory uncertainty while maintaining safety standards.
The United States Food and Drug Administration issued new guidance on Tuesday afternoon to clarify regulatory requirements for software apps used alongside prescription medications. The policy establishes specific standards for when drug developers must submit app content for regulatory review. The framework aims to reduce compliance friction for technology developers while preserving patient safety standards.
