Published in Blood Weekly, June 12th, 1995
"They're not a product, not a traditional drug," said Dr. Philip Noguchi, the FDA's gene therapy chief. "The question is when do you regulate cells themselves. ... It's not easy to know."
Transplants until now have been pretty straightforward: Doctors remove an organ from a dead patient, put it on ice and whisk it to another patient. The FDA has considered this a practice of medicine, something it doesn't regulate, Noguchi explained at a meeting of...
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