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.
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US FDA issues guidance on apps used with prescription drugs - Regional Media News
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 [...]
US FDA issues guidance on apps used with prescription drugs
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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