> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Cell/Gene Therapy Post-approval Data Meeting
- URL: https://www.fdaweb.com/cell-gene-therapy-post-approval-data-meeting/
- Published: 2023-03-24T12:00:00.000Z
- Updated: 2026-09-14T18:21:59.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5154063

CBER’s Office of Therapeutic Products is hosting a 4/27 virtual public listening meeting to obtain input 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 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,” an [agency notice](https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/methods-and-approaches-capturing-post-approval-safety-and-efficacy-data-cell-and-gene-therapy?ref=fdaweb.com) says. “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.” Specifically, FDA says it is interested in obtaining 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.”