Cerus says U.S. blood center customer submits BLA to FDA for Intercept
Cerus Corporation said that The Community Blood Center of Appleton, Wisconsin has submitted the first Biologics License Application to the U.S. FDA requesting allowance for interstate distribution of platelets that have been pathogen-reduced via the INTERCEPT Blood System. The Biologics License Application is a common procedure for blood centers to request permission by FDA to introduce a biologic product into interstate commerce. The FDA has up to 12 months to review each BLA submission. Until a blood center obtains a BLA, they are restricted to distributing INTERCEPT-treated products to hospitals within the state in which they are produced. While some blood centers may distribute primarily in state, many U.S. blood centers have extensive interstate distribution.