FDA to consolidate pharmaceutical product reviews

Pharmaceutical Representative, November, 2002 by Anonymous

The Food and Drug Administration has announced the consolidation of the agency's responsibility for reviewing new pharmaceutical products into its Center for Drug Evaluation and Research. Work currently performed by the FDA's Center for Biologics Evaluation and Research will be performed by the CDER.

"FDA's drug and biological product reviews have long been the gold standard for the world," said Lester M. Crawford, deputy commissioner of the FDA. "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."

Though the CBER will no longer evaluate biopharmaceuticals for approval, the FDA said the department will continue to function.

"This...

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