One question people often ask me is “Why is this taking so long?” and by “this” they mean getting stem cells to the patients who need them.
The answer to that question is complex, but one frequent complaint I hear is that the problem is the FDA being too strict. Almost exactly a year ago I did a post on the fact that neither ACT nor Geron had received FDA clearance for their early trials. Of course that has changed.
As a scientist who studies and worries a great deal about the tumorigenicity of stem cells, I personally think the FDA is doing its job of being extremely careful about the safety of stem cell-based drugs and the need for compelling pre-clinical safety data.
However, could the FDA be moving things along faster but preserving safety at the same time?
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