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U.S. Department of Health and Human Services

Drugs

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Unapproved Drugs Coordinator

The Unapproved Drugs Coordinator in the Office of New Drugs is available to assist you in obtaining information regarding the application process and can be reached at 301-796-0700. CDER recommends that any firm marketing an unapproved drug contact the coordinator and, at the same time, schedule a meeting with the relevant review division to discuss what data would be required to support an application for approval.