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FDA clinical hold review committee

Executive Summary

Will convene for its second meeting in late March, FDA announces in the Feb. 28 Federal Register. Composed of senior agency officials, the committee was created last October as part of an experimental procedure for reviewing clinical holds placed by the agency on experimental drug products. Products on clinical hold are selected for committee review by FDA Ombudsman Amanda Pedersen, who picks some at random through the Center for Drug Evaluation & Research's management information system and some from requests by sponsors. All meetings are closed due to the confidential information being discussed. Companies that would like the committee, at its March meeting, to take up products placed on clinical hold during FY 1991-1992 are requested to contact FDA by March 16.
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