On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

The Food and Drug Administration is kicking off a new approach to drug and device regulation that will use computer models and virtual patients to test cutting-edge products and speed up the ...

Neil Young once sang of adapting to a world ruled by data and digital minds in “Computer Age.” Today, that vision feels increasingly real as the Food and Drug Administration turns to artificial ...

CARY, N.C., Dec. 16, 2025 /PRNewswire/ -- InstantGMP™, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its ...

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 ...

An audit of the FDA’s computer network immediately after a cybersecurity breach last year detected vulnerabilities in the agency’s system. The report, released Tuesday by the Department of Health and ...

Turns out Elon Musk's FDA prediction was only off by about a month. After reportedly denying the company's overtures in March, the FDA approved Neuralink's application to begin human trials of its ...

The FDA awarded ImPACT Applications de novo clearance for two new devices to evaluate a patient’s cognitive function following a suspected brain injury or concussion. While the devices are not meant ...