Action Steps for FDA Diversity Action Plans

Simply developing a Diversity Action Plan to meet the US Food and Drug Administration (FDA) updated guidance is not enough.

Sponsors must demonstrate intent: That is, action plans must be both operational and executable. What’s more, the FDA is scrutinizing the quality of the data supporting these action plans. In this webinar, industry experts offered examples of how diversity action plans vary among therapeutic areas — and why one size does not fit all. They also explained why it’s important to incorporate action plans earlier in the clinical trial process, as well as consequences for failing to follow a submitted plan. The discussion included a deep dive into the FDA regulatory guidance:

• What studies are required to develop Diversity Action Plans
• What components must be included in each plan
• Enrollment goals for racial, ethnicity, sex, and age groups (including rationale for and measures to meet goals)
• When plans must be submitted to the FDA
• How to submit plans and receive feedback

Speakers:

• Brad Davis, Principal, Norstella
• Fenwick Eckhardt, Head of Diversity Strategy, Citeline

This program is sponsored by Citeline.

Note: This free session does not provide ACRP Contact Hours. | Expires September 25, 2027