Food and Drug Administration Beyond the 2001 Government Accountability Office Report: Promoting Drug Safety for Women

Sex is a biological variable that can impact health, disease, and response to treatment. Historically, many clinical drug trials were conducted largely on samples of men because women of childbearing age were excluded to reduce the risk of certain drugs causing serious birth defects. Yet, there is an expanding base of evidence of heterogeneity in both treatment effects and drug pharmacokinetics or pharmacodynamics in males versus females. Therefore, it is imperative that women are represented in clinical trials to identify and mitigate the safety risks that certain drugs may be more likely to pose specifically to women.

https://www.liebertpub.com/doi/10.1089/jwh.2020.8380?utm_source=Adestra&utm_medium=email&utm_term=&utm_content=article1&utm_campaign=JWH%20PR%20MAR%2010%202021