FDA issues final guidance on developing and labeling prescription drug apps

The FDA released its final guidance on Tuesday, outlining how drug sponsors should create, distribute, and label software applications that are used together with prescription medicines.

The guidance covers a range of app types, from those that attach to devices such as asthma inhalers to standalone tools that track symptoms, remind patients to take doses, or provide health coaching.

By clarifying regulatory expectations, the agency aims to help developers bring digital health tools to market more efficiently while ensuring they meet safety and labeling standards.