FDA Establishes Academic Centers to Study and Improve Drug and Device Review Processes

In an effort to improve how it reviews and evaluates medical devices and drugs, FDA is working with two Washington, DC–area universities to create academic centers devoted to regulatory science. The agency announced in a news release this week that the University of Maryland and Georgetown University will each receive a $1 million grant to establish a Center of Excellence in Regulatory Science and Innovation (CERSI). 

University researchers will collaborate with researchers from the agency to drive "innovation in medical product development" and "advance laboratory, population, behavioral, and manufacturing sciences," according to the release.

"These partnerships represent a critical, necessary, and creative investment—one that will benefit not just FDA and academia, but also American consumers and industry," FDA chief scientist Jesse L. Goodman said in the release.

The center at Georgetown will draw faculty from the school's medical and law programs.

"The very concept of regulatory science assumes sound regulation, which is the FDA's mission," Lawrence Gostin, a professor of global health law, said in a release issued by the university. "The regulation of food and drugs is one of the most important functions of government as the public comes to to rely on the FDA to ensure the safety and quality of food, vaccines, and medical products."

The center at the University of Maryland will draw researchers and staff from both the main campus (in College Park, MD) and the campus of the University of Maryland, Baltimore, according to a release issued by the school. That center will focus on bolstering FDA's ability to evaluate products and drugs in the preclinical stage, ensuring that the agency is prepared to review the most innovative products, and ensuring that the agency is able to maximize the data and information available to it. Researchers at that center will specifically work on how best to evaluate optical imaging devices and advanced materials such as nanostructured polymeric coatings. 

"This innovative new center will improve the lives of Americans," said Patrick O'Shea, vice president for research at the University of Maryland said in the release.