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FDA outlines proposal for computer-simulated testing of devices, drugs

The approval process for medical devices and drugs could incorporate computer modeling and virtual testing in an effort to modernize and streamline the regulatory pathway and make drugs more affordable, according to a proposal unveiled by the FDA on Friday. The agency is working on a family of virtual patients for device trials and databases for the development of treatments for Alzheimer's and Parkinson's disease, Commissioner Scott Gottlieb wrote in a blog post.

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