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US FDA issues guidance on apps used with prescription drugs

The guidance says device-linked apps generally belong on drug labels, while standalone trackers need evidence of clinical benefit or safe-use value.

Summary by WTVB
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…

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WTVB broke the news on Tuesday, October 20, 2026.
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