Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Center for Drug Evaluation and Research | CDER

Center 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 Home
          About FDA
          FDA Organization
          Center for Drug Evaluation and Research | CDER
          Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM)Center for Drug Evaluation and Research | CDER Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM)

    
Share
    Post
    Linkedin

    Email
    PrintThe Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM) consists of four review divisions: The Division of Pediatrics and Maternal Health (DPMH), the Division of Rare Diseases and Medical Genetics (DRDMG), the Division of Urology, Obstetrics and Gynecology (DUOG), and the Division of Pharmacology-Toxicology for Rare Diseases, Pediatrics, Urologic and Reproductive Medicine/Specialty Medicine (DPT-RPURM/SM). The Immediate office oversees the development, review, and regulation of applications for drug and biologic products reviewed in these divisions.

Physician Request for a Single Patient IND for Compassionate or Emergency Use
	Investigator-Initiated Investigational New Drug (IND) Applications
	Meetings and Workshops
	Guidance Documents
	Drug Safety and AvailabilityContact Us

**Mailing Address:**

Food and Drug Administration
Center for Drug Evaluation and Research
Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine
10903 New Hampshire Avenue
Silver Spring, MD 20993
Main Line: 301-796-2200   
Fax: 301-796-9744

Office and Division Contact Information (PDF - 77KB)

Resources

Office of New Drugs
	CDER Offices and Divisions
	Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality

                                                                                  Content current as of:
      04/24/2023Center 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
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop