Tuesday, August 14, 2012

MAKING SENSE OF THE FDA AND STEM CELLS – WSJ OPED « The Stem Cell Blog


When I was commissioner of the Food and Drug Administration (FDA) from 2005 to 2009, I saw firsthand how regenerative medicine offered a cure for kidney and heart failure and other chronic conditions like diabetes. Researchers used stem cells to grow cells and tissues to replace failing organs, eliminating the need for expensive supportive treatments like dialysis and organ transplants.
But the beneficiaries were laboratory animals. Breakthroughs for humans were and still are a long way off. They have been stalled by regulatory uncertainty, because the FDA doesn’t have the scientific tools and resources to review complex innovations more expeditiously and pioneer regulatory pathways for state-of-the-art therapies that defy current agency conventions. Fortunately, Congress may have an opportunity as soon as this week to begin changing that.

MAKING SENSE OF THE FDA AND STEM CELLS – WSJ OPED « The Stem Cell Blog

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