FDA official warns other drug makers not to copy Sarepta

(By Ed Silverman for STAT)

Any company that plans to mimic the approach taken by Sarepta Therapeutics to win regulatory approval of a drug should think twice. That was the blunt message delivered on Tuesday by a high-ranking US Food and Drug Administration official in the wake of simmering controversy over a recent decision to approve a Sarepta drug for Duchenne muscular dystrophy, a rare and fatal disease. Continue reading article here…….


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