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(a) Drug evaluation criteria.
So much for the science of drug evaluation.
One of the witnesses on Thursday was Janet Woodcock, an F.D.A. official in charge of drug evaluation.
The trial, called Courage —for clinical outcomes utilizing revascularization and aggressive drug evaluation — followed 2,287 patients treated in the United States and Canada from 1999 to 2004.
This, critics say, has made the division less efficient in reviewing drugs than the drug division, which concentrates strictly on drug evaluation.
Dr. Florence Houn, director of the agency's office of drug evaluation, said it was not yet known whether the problems were actually caused by the drug.
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Temple, who has for many years run the F.D.A.'s drug-evaluation department, is an owlish man with a short, thick mustache and circular glasses.
A recent memorandum of agreement between two groups within the FDA's Centre for Drug Evaluation and Research will systematically slow drug development and increase its costs.
Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, overruled the protests of her own staff to approve the drug.
Ultimately the FDA Center for Drug Evaluation and Research (CDER) is responsible for the approval of small molecules drugs.
Last August, the Gynuity team submitted their plans to the FDA Center for Drug Evaluation and Research and invited evaluators to raise any concerns.
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