SWHR Sends Letter to FDA in Study of Sex Differences in the Clinical Evaluation of Medical Products
In partnership with Leaders Engaged in Alzheimer’s Disease (LEAD) Coalition, the Society for Women’s Health Research submitted a sign-on letter to the FDA in response to the FDA’s Draft Guidance, “Study of Sex Differences in the Clinical Evaluation of Medical Products.”
With more than 300 organizations and individual researchers as signatories, in this comment the Society recommends the FDA incorporate a comprehensive framework that considers sex as a fundamental variable throughout drug and device development, approval, and post-market processes across disease and condition areas, including Alzheimer’s disease and Alzheimer’s disease-related dementias.
View the Letter
