On October 1, 2003, FDA transferred certain product oversight responsibilities from the Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER). This consolidation provides greater opportunities to further develop and coordinate scientific and regulatory activities between CBER and CDER, leading to a more efficient, effective, and consistent review program for human drugs and biologics. FDA believes that as more drug and biological products are developed for a broader range of illnesses, such interaction is necessary for both efficient and consistent agency action. Under the new structure, the biologic products transferred to CDER will continue to be regulated as licensed biologics.
To see which product classes have been transferred and which will remain at CBER, please refer to Transfer of Therapeutic Products to the Center for Drug Evaluation and Research.