“An action plan will be rolled out in the coming months to define the US Food and Drug Administration’s (FDA) approach to modernizing its technology infrastructure and framework, FDA Principal Deputy Commissioner Amy Abernethy said during a Thursday keynote at the Office of the National Coordinator for Health Information Technology’s (ONC) 3rd interoperability forum.”
“FDA modernization efforts have been underway in recent years, with the reorganizations of the Center for Devices and Radiological Health and the Center for Drug Evaluation and Research. The plan that FDA intends to roll out soon is a cross-center approach.”
“Abernethy said that FDA’s plan contains an agency-wide objective—advancing interoperability to inform regulatory decision-making in real-time. This, in turn, is intended to expedite determinations on submissions and improve regulatory oversight to increase patient access to medical products deemed to be safe and effective at a faster pace, as well as to enable earlier product interventions in the post-market setting.”
“Critically evaluating interoperable technologies, matching the best solutions to the characteristics of a patient at the point of care and ensuring that data are ‘available, reliable and well-characterized’ are the next steps in the journey toward interoperability, said Abernethy. As such, the focus of the plan is centered on modernizing FDA’s…” Read the full article here.
Source: FDA to Roll Out Modernization Plan in Push for Data Interoperability – By Ana Mulero, August 23, 2019. RAPS.
