Why Equi Sciences

The FDA’s current draft guidance offers recommendations for sponsors on creating and submitting Diversity Plans, which outline specific enrollment targets for racial and ethnic groups in clinical trials involving drugs, biological products, and devices. While the recommendations within this draft guidance are non-binding, they focus on establishing enrollment objectives based on race and ethnicity. Additionally, this legislation empowers the FDA to mandate that sponsors provide Diversity Action Plans detailing their enrollment targets, broken down by race, ethnicity, sex, and age group, to ensure a more inclusive approach to clinical trial participation.