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Executive Summary

Soviet delegation met with FDA Drugs and Biologics staff Dec. 15 to discuss drug post-marketing surveillance and evaluation as part of a two day round of courtesty meetings with FDA and top HHS officials. Delegation was headed by Vladimir Lepakhin, MD/PhD, deputy minister of the Soviet Ministry of Public Health, responsible for approving and purchasing pharmaceuticals for the USSR. He was accompanied by Vladimir Severtsev, chief of state quality control inspections of medicines and medical equipment. FDAers present included Acting Commissioner James Benson, Stuart Nightingale, CarlPeck, Gerald Meyer, Robert Temple, James Bilstad and Gerald Faich. Also present were HHS' James Mason and U.S. Pharmacopeia Director-designate Jerome Halperin.

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