Everyone involved in embryonic stem cell programs will be paying close attention to hearings the FDA is holding on how they plan to regulate the field. Developers want a much clearer idea of the regulatory pathway they'll have to follow to gain approvals. And they're looking for some assurances that the agency won't adopt the political leanings of the Bush administration--a longtime opponent of ESC research--when it comes to making critical decisions. It's a tough position to be in, notes Richard Garr, CEO of Neuralstem, which is advancing adult stem cell therapies. Garr's "nightmare" scenario: Unresolved safety issues surrounding stem cells could cause the agency to apply the brakes on considering new therapies.
- read the story in The Wall Street Journal
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