SWHR Encourages Inclusion of Women’s Voices in Patient-Focused Drug Development

Policy Engagement

Published 12/14/18

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

SWHR Engages With FDA on Patient-Focused Drug Development

SWHR seeks to ensure that meaningful input from women is included in the development and regulatory review of new medical products.

Learn More