The FDA's word on cell and gene therapies

The FDA announced in an article published in the current New England Journal of Medicine that the agency will apply existing regulations to somatic-cell therapy and gene therapies.

Industry representatives were pleased but not surprised by the announcement. "I don't think there was anything particularly new there. It has always been regulated through the CBER (Center for Biologics Evaluation and Research) and the regulations so far that we have experienced have been reasonable and fair and appropriate to the circumstances," said James Barrett, Genetic Therapy Inc. chairman and CEO...