Conference Program

Challenges in an Evolving Regulatory Landscape in the Digital Age: A Statistical Perspective (303674)

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*Matilde Sanchez-Kam, US Food and Drug Administration 

Keywords: FDA, PDUFA VII, DMAP, TMAP

With recent technological advances and availability of new data sources, we are experiencing exciting changes to the human medical product regulatory landscape. While these new areas have created challenges, they also present opportunities. In 2021, FDA issued its Data Modernization Action Plan (DMAP) to leverage the foundations laid by the agency’s Technology Modernization Action Plan (TMAP). The Plans shared the FDA’s vision for technology and data modernization to advance the Agency’s mission. This presentation will review the various FDA initiatives and PDUFAVII commitments in digital health technologies, Complex Innovative Designs, Real World Data/Real World Evidence and highlight the areas for which statisticians play a key strategic role in efficiently addressing current and future drug development and evaluation challenges.