Oncology drug office approves nine of ten applications in under three years


In case you wondered whether the stamp of approval was working over at the FDA's Office of Oncology Drug Products in the Center for Drug Evaluation and Research, it's working just fine. It might even be a little overworked.

According to a review published in the Journal of the National Cancer Institute, between July 1, 2005 and December 31, 2007, a full 60 new oncology drug and biological licensing applications and supplementary applications passed before them for review. They took action on 58 of them and approved 53 of them.

Among the many particulars, perhaps of most interest to patients is that 18 of these products were new molecular entities approved for new indications, while the other 35 were existing products approved for supplemental indications:

By Ross Bonander

Source: HemOncToday

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