From The Stage

CLIA Requirements for Gene and Cell Therapy Programs

Posted by / / Cell Therapy, Gene Therapy, Regulatory Considerations

It's a common misconception that all aspects of cell & gene therapy research and development are excluded from CLIA oversight. We take a closer look at testing and when CLIA requirements apply.

The FDA’s Response to an Increase in the Development of Gene and Cell Therapies: What It Means for Sponsors

Posted by / / Cell Therapy, Gene Therapy, Industry Update

The FDA has observed an unprecedented increase in the number of cell and gene therapy products entering the early stages of development. In a recent statement, the agency outlined new planned policies to help accelerate these innovations through the pipeline to clinical success. We discuss what this announcement means to sponsors.