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# Stakeholder Diversity Action Plan Comments
- URL: https://www.fdaweb.com/stakeholder-diversity-action-plan-comments/
- Published: 2024-09-26T12:00:00.000Z
- Updated: 2026-09-14T14:42:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157864

The Society for Women’s Health Research says it recognizes the critical role of increasing diversity across the research enterprise by reducing barriers to clinical trial participation for underrepresented and marginalized populations and applauds FDA for its commitment to trial diversity as seen in a draft guidance on diversity action plans to improve enrollment of participants from underrepresented populations in clinical studies. The society’s comment [letter](https://www.regulations.gov/comment/FDA-2021-D-0789-0159?ref=fdaweb.com) offers ideas for the agency’s consideration on these issues:

- sex as a biological variable;
- inclusion of diverse populations and intersectional identities;
- inclusion of pregnant and lactating populations; and
- best practices for recruiting diverse populations.

In its [response](https://www.regulations.gov/comment/FDA-2021-D-0789-0154?ref=fdaweb.com), the International Society for CNS Clinical Trials and Methodology provides comments from 32 experts on considerations for the format and content of diversity action plans, considerations for multi-region clinical trials, and pharmacology considerations. The letter also has specific line-by-line comments.

The Friends of Cancer Research [says](https://www.regulations.gov/comment/FDA-2021-D-0789-0150?ref=fdaweb.com) it supports the draft’s objectives and submits comments on monitoring and reporting progress toward meeting enrollment goals; timing and types of FDA meetings to discuss diversity action plans; and public posting of key information.