Division of Bone, Reproductive and Urologic Products (DBRUP)
Director: Hylton V. Joffe, M.D., M.M.Sc.
Deputy Director: Audrey Gassman, M.D.
Deputy Director of Safety: Christine Nguyen, M.D.
Chiefs, Project Management Staff: Margaret Kober and Jennifer Mercier
The Division of Bone, Reproductive and Urologic Products (DBRUP) regulates Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Biologics Licensing Applications (BLAs) for drugs and biologics intended for the prevention and treatment of reproductive and urologic conditions and conditions involving bone metabolism including:
- Gynecologic Disorders
- Menopausal Symptoms
- Sexual Dysfunction
- Benign Disorders of the Prostate and Bladder
Food and Drug Administration
Center for Drug Evaluation and Research
Division of Bone, Reproductive and Urologic Products
5901-B Ammendale Road
Beltsville, MD 20705-1266
Phone: (301) 796-2130
Fax: (301) 796-9897