Published in Medical Letter on the CDC and FDA, June 8th, 2003
FDA reviewed the application for this drug in less than 4 months. Velcade is the first in a new class of anticancer agents known as proteasome inhibitors.
Velcade was approved under the accelerated approval program. The program helps make promising products for serious or life-threatening diseases available earlier in the development process by allowing approval to be based on a promising effect of the drug, such as tumor shrinkage, before there is actual evidence of improved survival or other clinical...
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