USA – FDA lays out 2021 regulatory science areas of focus

Three strategic initiatives form the backbone of the regulatory science areas of focus for the US Food and Drug Administration in 2021, according to a new report.

The Focus Areas of Regulatory Science (FARS) issued on Monday “outlines topics that the FDA has identified as needing continued targeted investment in regulatory science research to facilitate the development of innovative products, provide data and methodology to inform regulatory decision-making and improve guidance to sponsors,” according to FDA Chief Scientist Denise Hinton.

The first of the three broad themes, outlined at the beginning of 2020 by FDA Commissioner Stephen Hahn, MD, was dubbed “Unleashing the Power of Data.” The second theme focuses on using innovation to increase choice and competition, while the third is aimed at empowering patients and consumers…