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Executive Summary

FDA's MANUFACTURING AND PRODUCT QUALITY DIVISION DIRECTOR will be Paul Vogel, who is succeeding outgoing division head Edmund Fry July 12. Fry will leave his position in the agency's Compliance Office to become executive director of the Parenteral Drug Association beginning in August, succeeding Frederick Carleton, who is retiring. Vogel has served briefly as director of the Division of Drug Quality Evaluation since replacing Buddy Stonecipher, who retired in late 1990. The division's deputy director, Charma Konnor, will become acting director in Vogel's place. Vogel has played a key role in tracking the generics investigations for FDA's compliance office. He assisted Fry as deputy of the Generic Drug Investigation Task Group appointed in 1989, and then headed the Generic Drugs Compliance Branch, established in Fry's division to continue the task group's functions on a permanent basis in July of 1990. Like Fry, Vogel gained experience in FDA compliance operations as a field investigator, joining the agency's Baltimore District staff in 1972. Vogel was transferred to FDA headquarters in the late 1970s and worked in various operational and management positions in the agency's field operations office over the next decade. In 1988, he joined Fry's drug manufacturing division in the Center for Drug Evaluation and Research's compliance office as chief of the division's non-sterile products branch. After a series of investigative positions in FDA field offices, Fry assumed leadership of CDER's drug manufacturing division in 1980. As the key participant in FDA good manufacturing practice (GMP) compliance issues, he has been active in helping determine the evolution of FDA policy during the past decade regarding process validation, aseptic processing, clinical supplies, bulk manufacturing and label controls.

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