HealthIT Answers October 25, 2020
By Amy Abernethy, MD, PhD, Principal Deputy Commissioner & Acting Chief Information Officer, and Vid Desai, Chief Technology Officer, FDA
On a daily basis, the U.S. Food and Drug Administration is responsible for making highly complex and consequential regulatory decisions. To meet this responsibility, the FDA must have a modern approach to the use of technology for its regulatory mission, such as the review of medical product applications and food safety, and other critical functions. The agency must also have a workforce that is empowered to be as nimble and as up-to-date as the products we regulate.
The FDA’s Technology Modernization Action Plan (TMAP) is the blueprint for this work. TMAP has three components: modernization of the FDA’s technical infrastructure...
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