chapter  12
22 Pages

The Biologic License Application

ByAlbert A. Ghignone

INTRODUCTION The first decade of the twentieth century brought some significant changes to the Center for Biologic Evaluation and Research (CBER). The center was reorganized and the Office of Therapeutic Products, the largest of CBER’s review groups, was transferred to the drug center. CBER now had three main review groups-The Office of Blood Research and Review, The Office of Vaccines Research and Review, and The Office of Cellular, Tissue, and Gene Therapies. The first two offices that oversaw blood products and vaccines had been part of the CBER review function for many years. The last office, The Office of Cellular, Tissue, and Gene Therapies was a new office for the CBER review groups. It was an office that would regulate the products generated on the cutting edge of biologic sciences.