FDA Launches Transformative Agency-Wide Data Modernization Plan

FDA is launching a sweeping data modernization plan in a bid to make its regulatory practices more efficient and to keep pace with rapid developments in biomedical technology and the use of real-world evidence. The agency said the plan will make FDA’s workflow more efficient amidst a surge of new medical product applications that the agency predicts will only intensify. The Technology Modernization Action Plan (TMAP), unveiled Wednesday (Sept. 18), has three elements: modernizing FDA’s technical infrastructure; developing new technology...