US FDA issues guidance on apps used with prescription drugs
XLV•The FDA issued guidance clarifying how drug companies should develop, distribute and label apps used alongside prescription medicines.
1. Guidance for drug apps
The guidance outlines when app content must be submitted to the FDA, when apps should be referenced in a drug’s prescribing information and what information companies need to provide. Apps linked to medical devices should generally be included in the associated drug’s label; standalone apps should be listed only if essential for safe and effective use or if they offer meaningful clinical benefit. The FDA said patient-facing information in companion apps will usually be treated as promotional material.
