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                Center for Drug Evaluation and Research | CDER

Center for Drug Evaluation and Research | CDER
            
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          Center for Drug Evaluation and Research | CDER
          Office of Nonprescription DrugsCenter for Drug Evaluation and Research | CDER Office of Nonprescription Drugs

    
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    PrintThe 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

Resources For You

Over-the-Counter OTC | Nonprescription Drugs
	Over-the-Counter (OTC) Drug Review | OTC Monograph Reform in the CARES Act
	OTC Monographs @ FDA
	Over-The-Counter Monograph Drug User Fee Program

                                                                                  Content current as of:
      06/20/2023Center for Drug Evaluation and Research | CDER
            
          
                        CDER Offices and Divisions
          Meeting Presentations | Drugs
          CDER Exclusivity Board


                        Accelerating Rare disease Cures (ARC) Program
          CDER Contact Information
          CDER Manual of Policies & Procedures | MAPP
          Frequently Asked Questions about CDER
          Reports & Budgets | CDER
 
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