The FDA is investing $2 million to support innovation centers with the goal of modernizing and improving the way drugs and medical devices are reviewed.
The federal watchdog agency said it will create two Washington, D.C.-based Centers of Excellence in Regulatory Science and Innovation at the University of Maryland and Georgetown University.
FDA officials said it chose to pilot the two centers in the Washington D.C. area to increase face time between the agency’s scientists and university researchers.
"These partnerships represent a critical, necessary and creative investment – one that will benefit not just FDA and academia, but also American consumers and industry," Jesse Goodman, FDA chief scientist said in prepared remarks. "The Centers of Excellence will create new scientific research, training and staff exchange opportunities for FDA and leading area institutions."
The center at the University of Maryland will be a joint effort between the University’s Baltimore and College Park campuses.
Researchers from both campuses will work with the federal watchdog agency’s scientists to develop new ways to assess the safety, efficacy, quality, and performance of FDA-regulated products.
Georgetown University’s Center of Excellence in regulatory science and innovation will be a collaborative undertaking at the Medical Center, Law Center and Georgetown’s School of Continuing Studies.
The federal watchdog agency’s medical device review and approval process has been getting some flak from lawmakers recently.
House Republicans introduced 10 bills aimed at the FDA’s medical device review and approval process.
The bills, sent to the Energy & Commerce Committee this week, detailed proposed measures to reform the predictability, consistency and transparency of the federal watchdog agency’s med-tech review process.