FDA TO CONSOLIDATE REVIEW RESPONSIBILITIES FOR NEW PHARMACEUTICAL PRODUCTS

Dr. Lester M. Crawford, Deputy Commissioner of the Food and Drug Administration, today 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 Dr. 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 vaccines and blood safety. These are top priority items critical to our national defense and public health. Moreover, CBER will be able to concentrate its expertise on such cutting edge biologic scientific areas as gene therapy and tissue transplantation."

Dr. Crawford has established a working group to develop by January an implementation action plan and time line for this consolidation. Dr. Crawford's deputy, Senior Associate Commissioner Dr. Murray M. Lumpkin, will chair this working group. The action plan will address issues related to the product and process logistics of the consolidation. Current FDA policy on generic biologics will not be affected by this decision.

In the interim, FDA advises companies to continue to work with CBER and CDER as they do at present until FDA issues further guidance on any change in oversight responsibilities and practices.

Any public comment or suggestions on this consolidation should be referred in writing to Dr. Lumpkin at HF-2, Room 14-71, 5600 Fishers Lane, Rockville, Md., 20857.

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