Guidance on Standardizing Terminology and Collection: Another Step in FDA’s Path to Increasing Diversity and Inclusion in Clinical Trials
FDA Law Blog: Biosimilars
FEBRUARY 5, 2024
If expanded choices are desirable, FDA recommends following the standards from the 2011 HHS Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status and provides more detailed categories from that guidance.
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