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  FDA to Consolidate Drug Approvals
Posted September 7, 2002 in Health News

WASHINGTON (AP) - The Food and Drug Administration said Friday it plans to shift responsibility for approving new drugs developed using biotechnology to its unit that had previously focused on traditional drugs.

The move was welcomed by industry, which has complained in the past that reviews of the biological drugs were too slow.

FDA Deputy Commissioner Lester W. Crawford said the change will consolidate responsibility for all drug reviews under the agency's Center for Drug Evaluation and Research.

That means shifting the biologically developed products from the Center for Biologics Evaluation and Research, which will continue to work in areas such as vaccines and blood safety.

"By carefully combining part of our present biologics review operation responsibilities with our drug review operation, FDA will be optimally positioned to ... review novel pharmaceutical products promptly and rigorously in an accountable and consistent manner," Crawford said in a statement.

The change will allow the biologics division to concentrate its scientific expertise and effort in other areas, he added, including gene therapy and transplantation.

Carl B. Feldbaum, president of the Biotechnology Industry Organization, said he is pleased with the move, although the details still have to be determined. The transfer will "bring lifesaving drugs to patients faster, alongside greater consistency in the drug development and review process," he said.

Crawford established a working group to develop a plan by January to put the change into effect.

On the Net:

Food and Drug Administration: http://www.fda.gov

Biotechnology Industry Organization: http://www.bio.org

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