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  5. Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine -Division of Urology, Obstetrics, and Gynecology(DUOG)
  1. Center for Drug Evaluation and Research | CDER

Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine -Division of Urology, Obstetrics, and Gynecology(DUOG)


The Division of Urology, Obstetrics, and Gynecology (DUOG) is committed to assuring the safety and efficacy of drugs and therapeutic biologics aimed at improving 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. 

DUOG 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 reproductive, and urologic conditions, including:

Obstetrics/Gynecology

  • 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

Meetings, Conferences, and Workshops (Drugs)

Director: Christine Nguyen (Acting)
Deputy Director: Audrey Gassman
Deputy Director for Safety: Catherine Sewell (Acting)

Director of Pharm/Tox for Rare Diseases, Pediatrics, Urologic and Reproductive Medicine: Mukesh Summan (Acting)

Regulatory Operations 
Chiefs of Project Management Staff:  Margaret M. Kober and Samantha Bell

Contact Us

Mailing Address:

Food and Drug Administration
Center for Drug Evaluation and Research
Division of Urology, Obstetrics, and Gynecology
5901-B Ammendale Road
Beltsville, MD 20705-1266
Phone: (301) 796-2130
Fax: (301) 796-9897

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