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                Center for Drug Evaluation and Research | CDER

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

    
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    PrintThe 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 obstetric, gynecologic, 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 ejaculationMeetings, Conferences, and Workshops (Drugs)

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

Office and Division Contact Information (PDF - 77KB)

Resources

Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine
	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
 
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