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Technology term

Prescription Drug Use-Related Software

Software distributed by or on behalf of a drug sponsor that presents an end-user output supplementing, explaining or otherwise relating to one or more of the sponsor’s prescription drugs. Under FDA guidance, the output may be treated as required or promotional drug labeling depending on the software’s role, evidence and connection to a device.

English

Prescription Drug Use-Related Software

Arabic

برمجيات مرتبطة باستخدام الأدوية الموصوفة

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FDA Draws a New Line Around Apps Paired With Prescription Drugs

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