FDA Releases Draft Guidance on the Approach for Developing a Race and Ethnicity Diversity Plan

The FDA has released a draft guidance document, “Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry; Availability.” The purpose of the guidance is to address Race and Ethnicity Diversity Plans and approaches for enrolling appropriate numbers of underrepresented populations in clinical trials.

The guidance includes sections on:

• • When a Race and Ethnicity Diversity Plan is Recommended
    
  • Tinmelines and Process for Submitting Race and Ethnicity Diversity Plans
    
  • Content of the Race and Ethnicity Diversity Plan (The Plan)
    
  • Examples of Selecting a DHT for a Clinical Investigation

View the complete draft guidance for a complete background and details including a table outlining recommendations for Race and Ethnicity Diversity Plans.

Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry; Availability Download Draft Guidance Now