FDA’s Center for Biologics Evaluation and Research  (CBER) Office of Therapeutic Products (OTP) announced  plans for a public listening meeting titled, “Methods  and Approaches for Capturing Post-Approval Safety and  Efficacy Data on Cell and Gene Therapy Products”1 . In  addition to the live meeting, FDA invited written public  comments for 30 days following the event, (via Docket  No. FDA-2023-N-0398). The FDA intends to use the  information in preparing new guidance for sponsors  in this area.The purpose of the meeting was to solicit input  from a wide range of stakeholders on methods and  approaches (e.g., use of real-world evidence, registries)  for capturing post-approval safety and efficacy data  for cell and gene therapy (CAGT) products. Given the  potential for long-lasting effects of CAGT products and  the often-limited populations that can be included in  clinical trials, especially in the case of rare diseases,  more extensive long-term surveillance is often  required. For example, FDA has been requiring up  to 15 years of post-approval data collection for gene  therapies that involve viral vectors in order to identify  delayed adverse events and verify clinical benefit. Aware of the challenges associated with conducting  CAGT long-term follow-up (LTFU) studies, FDA sought  presentations in four topic areas