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Executive Summary

FDA DIVISION OF BLOOD AND BLOOD PRODUCTS WILL BE SPLIT into two independent divisions. Approved Aug. 29 by FDA Associate Commissioner for Management and Operations Sharon Holston, the reorganization establishes the Division of Transfusion Science and the Division of Hematology. The new Division of Transfusion Science will be headed on a permanent basis by Joel Solomon, MD, currently director of the Blood Products Division. Ann Hoppe will serve as deputy director. The Division of Hematology will be headed by acting director John Finlayson, PhD, the current Hepatitis Lab director, and acting deputy director Genesio Murano, PhD, until a permanent director and deputy director are selected. The Division of Transfusion Science, which becomes responsible for the review of HIV and hepatitis test kits and blood banking, will include the labs of Retrovirology, Hepatitis and Blood Banking Practices. They will be headed, by J. S. Epstein, MD, Robin Biswas, and Ann Hoppe, respectively. Hoppe will serve in an acting capacity. Among the responsibilities of the Division of Hematology will be the review of blood-derived drug products, such as growth factors, immunoglobulins, thrombolytics, and therapeutic monoclonal antibody products. Three pre-existing labs -- Cell Components, Plasma Derivatives, and Cell Biology -- will join the division and retain their current directors. In addition, a newly created Lab of Hemastasis & Thrombosis, will review thrombolytic agents and blood clotting factors. It will be headed by William Fricke from the Lab of Plasma Derivatives. Center for Biologics Evaluation and Research Acting Director Gerald Quinnan, MD, sent out a memo throughout CBER on Aug. 31 asking staff to "begin sending documents for product review to the appropriate division immediately." The realignment of Blood Products Division staff will take place during September; however, separate budgets for each division will not be designated until Oct. 1, the beginning of FY 1991.

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