On February 4, 2022 10 AM ET, Global Liver Institute led an Externally-Led Patient-Focused Drug Development Meeting (EL-PFDD) on Primary Biliary Cholangitis (PBC). This online event is open to the public with registration required.
An EL-PFDD meeting of this magnitude will allow the U.S. Food and Drug Administration (FDA) and other stakeholders across the medical field to obtain a wide range of patients’ and caregivers’ input on PBC, including their perspectives on their condition, its impact on daily life, and the urgency around developing therapies.
The patient perspective is vital in helping to provide context when FDA makes regulatory decisions for new drugs. PFDD meetings give FDA and other key stakeholders, including medical product developers, health care providers, federal partners, an important opportunity to hear directly from patients, their families, caregivers, and patient advocates about the symptoms that matter most to them, the impact the disease has on patients’ daily lives, and patients’ experiences with currently available treatments. This input can inform FDA’s decisions and oversight both during drug development and during review of a marketing application.
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View the meeting below: