🧬 The FDA recommends up to 15 years of long-term follow-up for gene therapies that use integrating vectors, up to 15 years for genome editing, and up to five years for AAV vectors, each set by product-specific risk assessment. Follow-up frequently continues after licensure, and the agency may recommend a patient registry to support it. For a sponsor carrying several genetic-medicine assets, that obligation spans more than a decade per program. Meeting it depends on staying connected to patients through site turnover, relocation, and the years between milestones. The cohort has to remain re-contactable long after the last dose. 📖 Learn more about the operational barriers to long-term follow-up and how sponsors work around them here: eu1.hubs.ly/H0yjnkL0