Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a virtual public listening meeting on 27 April 2023 to solicit input on methods and approaches (e.g., use of real-world evidence (RWE), registries) for capturing post approval safety and efficacy data for cell and gene therapy products.

The rapid pace of innovation for cell and gene therapy products holds promise for transforming medicine and creating treatment options for patients living with difficult, rare, and often incurable diseases. With an increasing number of cell and gene therapy products in development and the potential for more of these treatments to become available to patients in the future, it is important to understand the full spectrum of long-term effects and collect accurate, timely, and comprehensive data to ensure these products remain safe, effective, and of high quality. The FDA is seeking input on methods, approaches, logistics, privacy concerns, and other aspects related to efficacy and safety data collection in the post-approval setting for cell and gene therapies.

This is a virtual public listening meeting and will be held via Zoom. The meeting is free and open to the public; however, registration is required. Early registration is recommended.

Registration will close on Wednesday, April 26, 2023 at 11:59 p.m. ET. A recording and other relevant meeting materials will be posted online following the event.

Please visit the FDA CBER OTP Public Listening Meeting — Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products site to register.