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Executive Summary

"As soon as they put it in front of me to sign," Office of New Drugs Director John Jenkins says, he will sign a memorandum of agreement setting out the duties of OND and Office of Safety and Epidemiology staff in reviewing safety issues for new drugs. A scheduled June 16 signing of the memo by Jenkins and OSE Director Gerald Dal Pan was delayed when a broken water main closed some FDA offices. Personnel in the two offices already are operating under the new procedures, the two assured those attending a June 26 town hall meeting during the Drug Information Association meeting in Boston. If staff cannot resolve their differences, the agreement calls for passing decisions up to the two office directors and then to CDER Director Janet Woodcock, if necessary. The latter will be a "rare occurrence," Jenkins and Dal Pan insist
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