US FDA clarifies labelling and review requirements for prescription drug apps

The US Food and Drug Administration (FDA) issued final guidance clarifying how pharmaceutical companies should label and submit apps used with prescription medicines. Apps linked to medical devices, such as asthma inhalers, should generally be described in the medicine’s prescribing information. Standalone apps, such as dose reminders and symptom trackers, need to be included if essential for safe and effective use or supported by evidence of clinical benefit.