FDA issues guidance to increase clinical trial participation by underrepresented racial and ethnic groups

Lexology April 18, 2022
Reed Smith LLP

This week, the FDA issued guidance to the pharmaceutical and medical device industries on how to develop a “Race and Ethnicity Diversity Plan” to ensure they are enrolling representative numbers of participants from underrepresented racial and ethnic populations in clinical trials. The guidance explains that “[a]dequate representation of these populations in clinical trials and studies supporting regulatory submissions helps ensure that the data generated in the development program reflect the racial and ethnic diversity of the population expected to use the medical product if approved, and may potentially identify effects on safety or efficacy outcomes that may be associated with, or occur more frequently within these populations.”

In the guidance FDA recommends that a Plan be submitted as part of...

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