Eye on FDA
A series focused on important FDA and related regulatory developments critical to the life sciences industry.
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Eye on FDA
On March 31, 2026, the Food and Drug Administration (FDA) published a notice in the Federal Register requesting information and public comment (RFI) on the use of digital health technologies (DHTs) in clinical investigations for drugs and biological products. To inform potential FDA activities in this area, the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are seeking feedback to better understand the opportunities and challenges associated with using these innovative technologies in clinical investigations.
Eye on FDA
FDA and the Department of Veterans Affairs (VA) announced last week that they plan to develop the first intergovernmental health artificial intelligence (AI) lab. This lab would test health-related AI applications for safety and effectiveness in a virtual lab environment. VA Undersecretary for Health Dr. Shereef Elnahal announced the news during the Veterans Health Administration Innovation Experience conference. The VA serves 9 million veterans—the largest health system in the country. The VA operates 170 medical centers nationwide, meaning that the VA could be well positioned to serve as a base for AI assurance labs across the country.
