FDA Issues Draft of Diversity Action Plans for Clinical Trials

The FDA published Wednesday its draft guidance for enhancing diversity in clinical trials to promote studies that are representative of the patients who will use the medical products.

The Food and Drug Administration’s long-awaited guidance describes the format and content of diversity action plans, which are intended to support medical product sponsors when submitting the products for certain clinical studies. The plans can help improve the data the FDA receives about the patients who may potentially use the medical product, according to the guidance.

The draft guidance also outlines the criteria and process the agency will use to evaluate a ...