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FDA OTC review process

Executive Summary

FDA Com. Young said at a March 12 meeting with representatives of the Proprietary Assn. that creation of an OTC standing advisory cmte. was "worth considering," according to an agency memo of the meeting. Young said, however, that elevation of the Division of OTC Drug Evaluation to an Office of OTC Drugs was "out of the question." P-A recommended creation of an OTC advisory cmte and elevation of the OTC division in a January letter to the agency.
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