FDA Plans Digital Health Technology Expansion As Part Of PDUFA VII

By Beth Wang / August 25, 2021 at 3:08 PM
FDA plans to use the next five-year prescription drug user fee deal to expand the role of digital health technologies in drug development and reviews and increase reliance on decentralized trials, the agency says in in its PDUFA VII commitment letter published Monday (Aug. 23). From fiscal 2023 through fiscal 2027, FDA plans to establish a digital health technology framework to guide regulatory decisions and identify at least three issue-focused demonstration projects to inform how digital health technologies should be...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.