Genzyme Accelerated Approval Creates Only Sluggish Trial Plans
Putting another difficult and expensive randomized trial of clofarabine on Genzyme's agenda didn't seem so harsh after FDA Office of Drug Oncology Products Director Richard Pazdur called the firm out for a not-so-accelerated approach to completing the validation trial required with Clolar's accelerated approval in 2004 to treat pediatric acute lymphoblastic leukemia.
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