FDA officials aim to stop misuse of the term ‘digital biomarker’


29 March 2022 - While a lot of researchers claim they are capturing digital biomarker data, they may in fact be collecting clinical outcomes assessment data according to some U.S. regulators. 

To clarify the differences, top U.S. FDA officials have defined digital biomarkers versus other kinds of data in a new article.

Read Regulatory Affairs Professional Society article

Michael Wonder

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Michael Wonder