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Executive Summary

CBER POLICY ON MANUFACTURING ARRANGEMENTS WILL BE COMPLETED BY AUTUMN, FDA's Center for Biologics Evaluation and Research Director Kathryn Zoon, PhD, told a July 13 meeting of the Food and Drug Law Institute in Washington, D.C. "This will clarify the center's position on a number of manufacturing arrangements -- shared, divided, short supply and contractual," Zoon said. The policy should be completed "in CBER by the fall of this year." The manufacturing policy statement was among several "major objectives" unveiled by Zoon that DBER aims to "accomplish within the next 18 months" unveiled by Zoon. She took over the CBER top spot on March 4 ("The Pink Sheet" March 2, p. 3); the FDLI meeting marked the first public discussion of specific priorities of CBER's new management. A second CBER manufacturing policy guide will be completed by the autumn, Zoon reported. The center and industry have been working on defining "changes which need to be reported and approved by CBER," she said. "Following these discussions, CBER will make the final decision on the report reduction and will make it available to the public." CBER also expects to complete revised points-to-consider documents for continuous cell lines and for in vivo monoclonal antibodies this autumn, Zoon added. Five other "major objectives" for CBER include: "a new policy to establish time frames and new procedures for product license application and establishment license application reviews"; a "refusal to file" policy; information management; training; and a CBER policy and procedure manual. Most of those initiatives grew out of discussions with CBER personnel conducted in the first weeks of Zoon's tenure. A summary of the CBER staff suggestions was made available in May ("The Pink Sheet" May 11, T&G-10). CBER's new Associate Director for Policy Coordination and Public Affairs Michael Beatrice will spearhead the information management and training initiatives, Zoon said. Information management will focus on tracking systems and "electronic submissions in all areas," she said. "We feel that the key to success in our ability to handle our workload in the future will be having a comprehensive state of the art management system," Zoon told the FDLI group. "CBER anticipates an ever-increasing workload in the future." Zoon noted that, as of 1991, CBER was overseeing nearly 300 "biotechnology" INDs as well as over 200 "traditional" biological INDs. The CBER reorganization plan is currently under review at HHS, Zoon said ("The Pink Sheet" June 1, p. 7). The center already has made commitments to hire 37 of 50 new personnel it has been promised. An agency-wide hiring freeze may complicate the hiring for the remaining 13 slots. The center already has brought on board all three associate directors called for under the reorganization. CBER's new acting Associate Director for Research is Kenneth Seamon, PhD, Zoon announced. Seamon joined FDA in 1983 and has served as CBER's molecular pharmacology lab chief since November 1987. He joins Beatrice and Associate Director for International & Medical Affairs Elaine Esber, MD, as an associate director. In his new role, Seamon will "insure the quality and consistency of scientific and technical standards applied to the evaluation of biological products among the offices," Zoon said. "He will coordinate scientific activities among CBER and other FDA components as well as other government organizations. In addition, he will supervise the activities of the scientific advisory committees." The center has established an "intercenter growth factor/wound healing working group" to promote consistency among CBER, the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health in their policies towards neurotrophic growth factors, Zoon informed FDLI. The group is drawn from all relevant areas of the center, CBER said, and invites the participation of the other centers as well as outside consultants. CBER had a similar working group devoted to the hematopoietic growth factors prior to their licensure. "We're also looking at a long term safety assessment of growth factors in collaboration with our colleagues at the National Center for Toxicological Research the National Institutes of Health," Zoon added. In the manufacturing and compliance area, "our interactions with the field...have increased and joint inspections and training programs have been initiated," Zoon said. "This is in the blood area as well as in the area of the biotechnology products."

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