Business · 30/01/2020Updated: 10/17/2026 · 1 min read

FDA Releases Final Guidance on Long-Term Follow-Up for Human Gene Therapy Products

The FDA has released a final guidance document providing recommendations for sponsors of human gene therapy products on designing long-term follow-up observational studies to collect data on delayed adverse events, replacing previous guidance from 2006 and updating a 2018 draft.