At a Food and Drug Administration cell and gene therapy (CGT) roundtable last June, most speakers pushed for the agency to soften oversight of the field.
It seems they got their wish. The agency recently released new documents announcing CGT oversight changes to make the system much more flexible.
There’s a somewhat unpredictable tradeoff here. The new, flexible system may be positive in some ways —for instance, it could accelerate beneficial CGT development, which is much needed. But recipients of some of these emerging therapies will face more risks. There could also be new risks for the whole CGT field — and even the FDA itself.
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