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CDER ombudsman utilization

Executive Summary

The Center for Drug Evaluation & Research Ombudsman's office reports receiving more contacts from industry than from consumers in 2005. About one-third of those industry contacts concerned jurisdictional and drug development assistance; the office fielded more than 200 informal questions regarding FDA review jurisdiction. Among consumers, concerns about importing drugs from Canada and FDA non-approval of Plan B over-the-counter sales carried over from 2004, while consumers commented less often than last year on direct-to-consumer advertising and FDA advisory committee members...

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