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  1. Center for Drug Evaluation and Research | CDER

Office of Nonprescription Drugs


The Office of Non-Prescription Drugs (ONPD) consists of two review divisions: The Division of Nonprescription Drugs I and Nonprescription Drugs II. The Immediate office oversees the development, review, and regulation of nonprescription products (marketed under Over-the-counter (OTC) monographs and under NDAs) reviewed in these divisions. OTC drugs play an increasingly vital role in America's health care system.

Director: Theresa Michele, M.D. (Acting)
Deputy Director: Karen Mahoney, M.D. (Acting)

Regulatory Operations
Director of Project Management Staff:
Celia Peacock (Acting)

Contact Us

Mailing Address: 

Food and Drug Administration
Center for Drug Evaluation and Research
Office of Nonprescription Drugs
10903 New Hampshire Avenue WO22 Stop 5411
Silver Spring, MD 20993

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