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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  6. Office of Nonprescription Drugs
  1. CDER Offices and Divisions

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. 
Deputy Director: Karen Murry, M.D. 

Regulatory Operations
Director of Project Management Staff: Celia Peacock

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
301-796-0138

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