🧬FDA Guidance on Postapproval Safety and Efficacy for CGT Products
Postapproval Methods To Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Draft Guidance for Industry; Availability
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a draft document entitled "Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Draft Guidance for Industry." The draft guidance document discusses methods and approaches for capturing postapproval safety and efficacy data for cell and gene therapy (CGT) products.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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The document outlines FDA guidance on capturing safety and efficacy data for cell and gene therapy (CGT) products post-approval, highlighting compliance requirements for businesses in the biotech sector. Companies will need to adhere to these regulatory standards to ensure product safety monitoring, affecting operational costs and potentially revenue.