In comments to the Food and Drug Administration (FDA) on its Patient-Focused Drug Development (PFDD) Program, SWHR encouraged inclusion of the unique perspectives of women as patients, caregivers, and family decision-makers across the lifespan.
PFDD’s goal is to better integrate the patient’s voice into drug development and regulatory decision-making, and as such, SWHR suggested the program pay particular attention to patient population diversity, especially sex and gender differences. Additionally, SWHR called for the terms “sex” and “gender” to be added to the FDA PFDD glossary to achieve shared understanding across stakeholder groups regarding the importance of these terms.
READ SWHR’S FULL COMMENTS HERE
