Combination Products No Longer Reviewed by CBER

Erik Swain

Under a proposed FDA reorganization, packaging and labeling for new drug-biologic combination products will be reviewed solely by the agency's Center for Drug Evaluation and Research (CDER).

Currently, applications for such combination products are often reviewed by both CDER and the Center for Biologics Evaluation and Research (CBER). But on September 6, 2002, FDA announced that all responsibility for reviewing new pharmaceutical products and their packaging and labeling, regardless of whether any biologic components are involved, will fall to CDER. At that point, CBER will concentrate its efforts in areas such as vaccines, blood safety, gene therapy, and tissue transplantation. The agency's policies on generic biologics will not be changed.

The agency has established a working group to develop, by January 2003, an action plan and timeline for implementation of the change. Until guidance on the change is issued, FDA advises drug and biologics manufacturers to continue working with CDER and CBER as they have been.

Comments or suggestions should be sent in writing to Murray M. Lumpkin, MD, senior associate commissioner, FDA, HF-2, Room 14-71, 5600 Fishers Lane, Rockville, MD 20857.

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