Today, 304 LEAD Coalition member organizations and allies sent a joint public comment letter to the U.S. Food and Drug Administration (FDA) regarding its draft guidance for the study of sex differences in the clinical evaluation of medical products (Docket No. FDA-2024-D-4245). The letter, co-led by the Society for Women’s Health Research, supports the draft guidance, urges the FDA to implement a comprehensive framework that considers sex as a fundamental variable throughout drug and device development, approval, and post-market processes across disease. The letter also makes three sets of recommendations. Read the letter here.