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Regulatory Issues

FDA to consolidate review responsibilities for new pharmaceutical products

Published in Medical Letter on the CDC and FDA, October 13th, 2002

Dr. Lester M. Crawford, deputy commissioner of the U.S. Food and Drug Administration (FDA), has announced the consolidation of FDA's responsibility for reviewing new pharmaceutical products into its Center for Drug Evaluation and Research (CDER).

This work is currently performed in part by FDA's Center for Biologics Evaluation and Research (CBER) and in part by CDER.

"FDA's drug and biological product reviews have long been the gold standard for the world," said Crawford. "By carefully combining part of our present biologics review operation responsibilities with our drug review operation, FDA will be optimally positioned to uphold that gold...

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