The FDA Initiative to Assure Racial and Ethnic Diversity in Clinical Trials.

On April 13, 2022, the Food & Drug Administration (FDA) issued a new draft guidance for industry for "developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials ." In so doing, the FDA reaffirmed the reality that racial and ethnic minorities remain underrepresented in clinical trials. FDA Commissioner Robert M. Califf, MD offered that the "U.S. population has become increasingly diverse, and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health." Commissioner Califf went on to pledge that "achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities." This Commentary is dedicated to a thorough review of the new FDA policy and the implications thereof.