2025-18650: Postapproval Methods To Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Draft Guidance for Industry; Availability
Public comment closed .
Get alerted when the next rule lands
New rules open for comment on their own schedule. Pick how you want to hear about them — we email you when one appears.
Publishing to members? Embed a live rule tracker on your own site — the proposed rules in your area and the comment deadlines closing on them, updating themselves. Free, one line of HTML.
Create a free account & build one →Summary
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled "Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Draft Guidance for Industry." The draft guidance document discusses methods and approaches for capturing postapproval safety and efficacy data for cell and gene therapy (CGT) products. Given the potential for long-lasting effects of CGT products, and the generally limited number of participants treated in clinical trials, the collection of postapproval study data for CGT products is important for gathering data on product safety and effectiveness over time.
The agency’s own summary, as published.
Don't miss the comment window
One Click Politics alerts you on every deadline, hearing, and rule change.
See all rules with comments due soon →