ABSTRACT
For facilities that will ultimately produce biological products, licensing the facility is a complicated process that has changed in recent years. In 1996, CBER moved away from the dual licensing model that utilized the Establishment Licensing Application (ELA) and the Product Licensing Application (PLA). The use of the ELA/PLA model was ended as of October 20, 2000. Now, a single licensing model is used, as defined in the Biological Licensing Application (BLA). This shift was implemented to allow CBER and CDER to harmonize their respective application formats under the single form 356h (Figure 11.1).
