The Food and Drug Administration (FDA) announced in September that its Center for Drug Evaluation and Research (CDER) would have sole responsibility for reviewing new pharmaceutical products. This work is currently performed in part by FDA’s Center for Biologics Evaluation and Research (CBER) and in part by CDER.
The consolidation will allow CBER to concentrate its scientific expertise and effort in the areas of vaccines and blood safety, explains Lester M. Crawford, DVM, PhD, FDA deputy commissioner. "Moreover, CBER will be able to concentrate its expertise on such cutting-edge biologic scientific areas as gene therapy and tissue transplantation."
Crawford has established a working group to develop by January an implementation action plan and time line for the consolidation. 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.