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Jump to Key Points Oct 20 (Reuters) - The US FDA on Tuesday issued guidance aimed at clarifying how drug companies can develop, distribute and label apps used alongside their prescription medicines.
Here are some details:
• The policy outlines when content in such apps must be submitted to the US Food and Drug Administration, when those apps should be referenced in a drug's prescribing information, and what information companies need to provide to the health regulator.
• Apps linked to medical devices, such as software paired with an asthma inhaler, should generally be included in an associated drug's label, the FDA said
- FDA guidance clarifies when prescription-drug companion apps need regulatory submission.
- Device-linked apps (e.g., inhaler software) generally belong in drug labeling.
- Standalone symptom/reminder/coaching apps listed only if essential or clinically beneficial.
- App-displayed patient info usually treated as promotional material.
- Guidance aims to reduce uncertainty while preserving safety/effectiveness standards.
• Standalone apps that track symptoms, provide reminders or offer coaching should be listed in the label only if these apps are essential for the medicine's safe and effective use or offer meaningful clinical benefit, it said
• In most cases, information displayed to patients through a companion app will be treated as promotional material, in line with the regulator's approach to other forms of drug advertising
• The FDA said the guidance intends to reduce regulatory uncertainty for drugmakers and technology developers while maintaining safety and effectiveness standards
(Reporting by Christy Santhosh in Bengaluru; Editing by Aseem Gujar)
