Regulatory Trends In Cell And Gene Therapies

By, Lina Jamis, M.S., and Rebecca Roberts, Ph.D.

There have been several recent indications that the FDA plans to provide greater support for cell and gene therapies, addressing key issues that continue to impede their development. Some of these issues include a lull in cell and gene (CGT) product approvals, the financial feasibility of generating small-batch CGT products for ‘ultra-rare’ diseases, and the continued demand and growth of the CGT industry. Despite these problems, the FDA’s is showing a surge of support for these therapies that will hopefully result in an increased number of therapies making it through the final stages of clinical trials and gaining FDA approval.

Explore the discussion surrounding CGT products, specific FDA initiatives to address these growing issues, broader regulatory trends, and the predicted growth of CGT products in the coming years.