Despite affecting up to 15% of women and a $15 billion annual economic burden in the U.S. alone, polycystic ovary syndrome (PCOS) has yet to see any treatments specifically for the disorder approved by the U.S. Food and Drug Administration (FDA). To address this critical gap in care, PCOS Challenge: The National Polycystic Ovary Syndrome Association has organized the PCOS Externally-Led Patient-Focused Drug-Development Meeting (PCOS EL-PFDD Meeting) as a listening session for the FDA, product developers, clinicians, and academic researchers to hear directly from individuals with PCOS about the health effects and daily impacts of the condition, their treatment goals, and their decision factors when seeking out or selecting a treatment. The PCOS EL-PFDD meeting is being conducted as a parallel effort to the FDA’s PFDD initiative to more systematically gather patients’ perspectives on their conditions and available therapies to treat their conditions. The input from EL-PFDD meetings can inform the FDA’s oversight during drug development and marketing application reviews.
The PCOS EL-PFDD Meeting will take place on Friday, November 3, 2023, from 10:00 AM to 2:30 PM EST at Samuel Riggs IV Alumni Center in College Park, Maryland. The event will be hybrid, enabling participation both in-person and via an interactive live stream. Read More…
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