Zdrowie i gospodarka · 20/06/2016

FDA Releases Draft Guidance on Age, Race, and Ethnicity Data in Medical Device Clinical Studies

The Food and Drug Administration (FDA) has released a draft guidance document outlining its recommendations for evaluating and reporting age, race, and ethnicity data in medical device clinical studies, aiming to enhance data quality and consistency. The document is not yet final and does not take effect until further notice.