FDA Signals Willingness to Grant Regulatory Flexibility for Cell and Gene Therapy Products in CMC Reviews

Executive Summary US FDA official says that the complexities involved in producing cell and gene therapies necessitate a “new manufacturing paradigm” in evaluating biologics license applications. For such therapies, the agency is willing to grant regulatory flexibility in certain areas of its chemistry, manufacturing and controls review.

Executive Summary

US FDA official says that the complexities involved in producing cell and gene therapies necessitate a “new manufacturing paradigm” in evaluating biologics license applications. For such therapies, the agency is willing to grant regulatory flexibility in certain areas of its chemistry, manufacturing and controls review.

3d illustration of T cells or cancer cells
Source: pink.pharmamedtechbi.com