FDA to use computer modeling to step up device, drug regulation

As required by the 21st Century Cures Act, FDA Commissioner Gottlieb is working to modernize the drug approval process and innovate drug and device regulation.
By Jessica Davis
12:47 PM
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FDA drug and medical device regulation

The U.S. Food and Drug Administration plans to integrate virtual testing and computer modeling into the regulatory approval process for manufacturers, the agency revealed in a proposed work plan released Friday. The proposal is required as part of the 21st Century Cures Act.

The move would help reduce costs and speed-up the regulatory approval process. Officials said the use of the technology is part of the agency’s plans to modernize its regulatory approval process.

As part of the 21st Century Cures Act, the proposed plan will help meet outlined requirements for improving medical product innovation.

“We need to make sure that our regulatory principles are efficient and informed by the most up-to-date science,” FDA Commissioner Scott Gottlieb, MD, wrote in a blog post.

“We don’t want to present regulatory barriers to beneficial new medical innovations that add to the time, cost, and uncertainty of bringing these technologies forward if they don’t add to our understanding of the product’s safety and benefits,” he said.

Computer models and simulations can help develop and better evaluate both devices and drugs, Gottlieb said. Specifically, modeling and simulation are critical to improving the organization of advanced data sets and alternate study designs.

The FDA will also collaborate with outside parties to improve the infrastructure of technology development, said Gottlieb.

Currently, the FDA’s Center for Drug Evaluation and Research is using modeling and simulation for predicting clinical outcomes, informing trial designs and providing evidence of drug effectiveness.

The agency will release updated guidance for use of these tools for drug development in the near future.

Twitter: @JessieFDavis
Email the writer: jessica.davis@himssmedia.com


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