Computer simulations may get a role alongside human testing as part of an effort to bring new medications and medical devices to market more quickly and cheaply.
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 price of new technology affects the ability of people to access these new treatments,” FDA Commissioner Scott Gottlieb wrote in a blog post. “We therefore need to be mindful of the costs of our regulatory processes, to the degree that these costs also affect the availability of new innovations, and the way that they are ultimately priced.”
The FDA has begun using computer modeling to build databases to help researchers predict how new treatments for Parkinson’s and Alzheimer’s disease will perform. And the agency is developing a family of “virtual patients” for testing new devices, Gottlieb said in the blog post.