FDA Scolds Drugmakers For Missing Pediatric Study Deadlines

Law360, New York (August 26, 2013, 4:06 PM EDT) -- The U.S. Food and Drug Administration on Monday accused Genzyme Corp. and two other drugmakers of failing to satisfy obligations to study previously approved products in children, the first examples of public chidings recently mandated by Congress.

In letters posted on its website, the FDA complained about incomplete pediatric clinical trials involving Genzyme kidney drugs Renvela and Hectorol, Amedra Pharmaceuticals LLC’s allergic shock medicine Twinject and The Medicines Co.’s blood pressure treatment Cleviprex.

"We believe this important step demonstrates our ongoing commitment to getting these studies...
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