@article {Adashi366, author = {Eli Y. Adashi and I. Glenn Cohen}, title = {The FDA Initiative to Assure Racial and Ethnic Diversity in Clinical Trials}, volume = {36}, number = {2}, pages = {366--368}, year = {2023}, doi = {10.3122/jabfm.2022.220290R1}, publisher = {The Journal of the American Board of Family Medicine}, abstract = {On April 13, 2022, the Food \& Drug Administration (FDA) issued a new draft guidance for industry for {\textquotedblleft}developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials .{\textquotedblright} 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 {\textquotedblleft}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.{\textquotedblright} Commissioner Califf went on to pledge that {\textquotedblleft}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.{\textquotedblright} This Commentary is dedicated to a thorough review of the new FDA policy and the implications thereof.}, issn = {1557-2625}, URL = {https://www.jabfm.org/content/36/2/366}, eprint = {https://www.jabfm.org/content/36/2/366.full.pdf}, journal = {The Journal of the American Board of Family Medicine} }