Biomedical Research

FDA Contemplates Transplant Regulations

Published in Blood Weekly, June 12th, 1995

The U.S. Food and Drug Administration (FDA) is beginning to wrestle with how to regulate cells and organs being transplanted into patients, an area until now largely left to the discretion of doctors.

"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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Source: Blood Weekly (1995-06-12)

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