SWHR Contributes to Patient-Focused Drug Development Workshop

Policy Engagement

Published 2/16/18

SWHR issued comments to the federal Food and Drug Administration (FDA) regarding its recent workshop on methodological approaches for collecting comprehensive and representative input from patients and caregivers. The workshop was part of the ongoing Patient-Focused Drug Development (PFDD) initiative. SWHR’s overall comments focused on the need to include consideration of the unique experiences of women as patients, caregivers, and family decision-makers across the lifespan.

SWHR encouraged the addition of both the terms “sex” and “gender” to the FDA PFDD glossary, in order to achieve shared understanding of the importance of these terms across stakeholder groups. They also encouraged the FDA to develop standards for data collection and management, and to harmonize recommendations across PFDD guidance documents.

See SWHR’S Full Comments Here