Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products

Thank you for the opportunity to submit comments to the Food and Drug Administration’s (FDA) draft guidance “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products.” As the leading organization of professionals working with healthcare data and protected health information (PHI), the American Medical Informatics Association (AMIA) supports the Administration’s efforts to standardize collection and reporting race and ethnicity data in clinical studies and clinical trials for FDA-regulated medical products. 

Read the full comment letter below.