> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# BIO on Collecting Race, Ethnicity Data
- URL: https://www.fdaweb.com/bio-on-collecting-race-ethnicity-data/
- Published: 2024-05-09T12:00:00.000Z
- Updated: 2026-09-14T14:30:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156953

The Biotechnology Innovation Organization (BIO) says FDA should consider including greater discussion on the rationale for its draft guidance on the collection of race and ethnicity data in clinical trials and clinical studies for FDA-regulated medical products. In a comment [letter](https://downloads.regulations.gov/FDA-2024-N-1157-0002/attachment%5F1.pdf?ref=fdaweb.com), it says the discussion should include the consequences, both for the sponsor and the public, of incomplete or inaccurate race and ethnicity data collection and reporting in clinical studies.

“Race and ethnicity have varying implications on a patient’s outcomes and lived experience depending upon one’s socio-political context,” BIO writes. “We encourage the agency to consider hosting public discussion or workshops as a basis for developing public recommendations for the optional collection of information on other social factors that drive disease disparities, such as income, education, geographic location, sexual orientation, gender identity, disability status, country of origin, and genetic ancestry information.”

BIO also includes specific line-by-line comments.