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  1. Center for Drug Evaluation and Research | CDER

Division of Bone, Reproductve and Urologic Products


The Office of New Drugs is undergoing a reorganization. This site may be updated in the near future. Please check back often. For more information, please visit Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality.

Director: Hylton V. Joffe, M.D., M.M.Sc.
Deputy Director: Audrey Gassman, M.D.
Deputy Director for Safety: Christine P. Nguyen, M.D.

Chiefs, Project Management Staff: Margaret M. Kober, R.Ph., M.P.A. and Jennifer Mercier 

Mission: The Division of Bone, Reproductive, and Urologic Products (DBRUP) is committed to assuring the safety and efficacy of drugs and therapeutic biologics aimed at improving bone, reproductive, and urologic health. Our work is guided by our commitment to public health, pursuit of excellence in scientific and regulatory knowledge, multidisciplinary collaboration, and strong work ethic. 

DBRUP regulates Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Biologics License Applications (BLAs) for drugs and therapeutic biologics intended for the prevention or treatment of bone, reproductive, and urologic conditions, including:

Bone 

  • Osteoporosis
  • Fracture repair
  • Other metabolic bone diseases

Reproductive

  • Abnormal uterine bleeding
  • Cervical dysplasia
  • Contraception
  • Endometriosis
  • Female infertility
  • Lactation disorders
  • Medications used as part of assisted reproductive technology programs
  • Menopausal symptoms
  • Pelvic pain
  • Premenstrual Dysphoric Disorder
  • Prenatal vitamins
  • Preterm labor
  • Sexual dysfunction
  • Sexual pain disorders
  • Uterine fibroids

Urology

  • Benign prostatic hypertrophy
  • Bladder pain disorders
  • Erectile dysfunction
  • Male hypogonadism
  • Male infertility
  • Overactive bladder disorders
  • Peyronie’s disease
  • Premature ejaculation

Mailing Address:
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

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