Sometimes that’s hard to say because many times, we have what’s often called a shared responsibility for regulating such products in which case it’s possible that both CBER and CDER may regulate a particular type of product of this nature, but one of the centers will take the lead in any regulation or enforcement issues. CBER has taken the lead, and of course, they’re probably looking at the biologics regulations, the nature of biologics and the need to have tighter controls, more stringent controls because of the nature of the process. You’re dealing with cell culture; you’re dealing with processes where contamination becomes an issue right from step one. These are some of the main differences between these types of processes and chemical synthesis. In chemical synthesis of APIs, generally contamination with microorganisms is not an issue in the early steps. It only becomes an issue generally when you’re producing an API for sterile drug production. So again, we’re trying to recognize the differences in the manufacturing processes.
