https://www.fda.gov/news-events/2024-cber-patient-and-care-partner-listening-meetings?utm_medium=email&utm_source=govdelivery
On September 20, 2024, the FDA Center for Biologics Evaluation and Research (CBER) is hosting a public patient listening meeting to better understand patient and care partner perspectives on safety considerations and long-term follow-up for approved gene therapy treatments for rare diseases.
The objectives of this listening meeting are to hear from patients and care partners on their perspectives on short-term and long-term risks of approved gene therapy products, to learn what types of information patients would find helpful in their decision-making when considering gene therapy, to learn about their considerations and experience with participating in long term post-market studies, and to help inform patient-centered protocols for long-term studies that include gene therapy outcomes.
The meeting will be divided into two sessions and patients, advocates, and caregivers are encouraged to request to speak during the registration process. The deadline to request to speak is Friday, August 30, 2024, at 11:59 p.m. ET.
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