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FDA to consolidate review responsibilities for new pharmaceutical products.(Brief Article)

Vaccine Weekly

| October 09, 2002 | COPYRIGHT 2002 NewsRX. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

2002 OCT 9 - (NewsRx.com & NewsRx.net) -- 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 standard by continuing to review novel pharmaceutical products promptly and rigorously in an accountable and consistent manner.

"In addition, this consolidation will allow CBER to concentrate its scientific expertise and effort in the crucial areas of ...

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