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Executive Summary

FDA BIOLOGICS AND FIELD STAFF "CROSS-TRAINING" in the biotechnology inspection area is under discussion at the agency, according to the Center for Biologics Evaluation and Review (CBER). The cross-training concept was one of the agenda items at a late March meeting of the agency's Biologics Field Committee. FDAers say that CBER and the field investigation staff are continuing to discuss the possibilities for such an initiative. CBER Product Certification Division Acting Director Michael Beatrice indicated that the agency is exploring the possibility of closer communication between CBER and the field staff in the biotechnology inspection area at a GMP conference sponsored by the University of Georgia in late March ("The Pink Sheet" April 1, p. 8). However, in a memo to headquarters and field staff issued during the week of April 15 in response to questions generated by the article in "The Pink Sheet," Beatrice clarified that he was not specifically in favor of, nor was it the agency's current policy to pursue turning over CBER's inspection responsibilities to the FDA field offices. Asked at the University of Georgia meeting if a "team approach" between CBER and field investigators in handling biologics inspections was being considered, Beatrice suggested that "some mechanism for" the sharing of inspection responsibilities could be among possible solutions available to CBER as a way of reducing workload pressures as the crunch of biotech product INDs proceed to the licensing stage. "As a preclude to what might happen in the future -- and I don't know if it is going to happen ever or soon or whatever -- we are getting together and we are going to meet and discuss possible transitional phases" such as "cross-training" in the biotechnology area, Beatrice said. He pointed to the potential benefits such training could have in the "tradeoff" of CBER's technical knowledge in the biotech area with field good manufacturing practice expertise. FDA is considering closer cooperation between CBER and the field inspection force in response to the growing number of firms that are manufacturing both biologic and drug products in the same facility. Proposals for field office handling of the ongoing inspection responsibilities for "integrated" facilities have received discussion over the past two years, although no formal resolution has resulted from these discussions. A mechanism for joint CBER/field inspections of these facilities is now under consideration at FDA as a solution to the problem of overlapping inspection responsibilities.

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