US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.

small green plant sprouting out of crack in concrete.
The FDA has been able to help revive stuck rare disease programs as its thinking and experience with clinical trial designs evolved. (Shutterstock)

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