Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM)
The 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 Availability
Director: Janet Maynard, MD, MHS
Deputy Director: Christine Nguyen, MD (Acting)
Regulatory Operations
Director, Project Management Staff: Pamela Lucarelli
Contact 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
Resources For You
- 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