The Division of General Endocrinology (DGE) regulates Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Biologics Licensing Applications (BLAs) for drugs and biologics intended for the prevention, treatment, or diagnosis of conditions including:
- Growth hormone deficiency (GHD) and growth hormone-related conditions, including pediatric GHD-related short stature, adult GHD, Prader-Willi syndrome, small for gestational age without catch-up growth by age 2 years, Turner syndrome, pediatric renal insufficiency, idiopathic short stature, AIDS wasting and cachexia, achondroplasia
- Adrenal and ACTH disorders
- Anabolic steroids
- Hypo- and hyperthryoidism
- Developmental disorders (accelerated or delayed puberty)
- Cushings sundrome
- Geriatric frailty and sarcopenia
- Vitamin deficiency (except vitamin D)
Director: Theresa Kehoe M.D.
Deputy Director: Naomi Lowy, M.D.
Deputy Director for Safety: Theresa Kehoe, M.D. (acting)
Safety Regulatory Project Manager: Elisabeth Hanan, M.S. (acting)
Associate Director for Labeling: LaiMing Lee, Ph.D.
Chief, Project Management Staff: Elisabeth Hanan, M.S.
Food and Drug Administration
Center for Drug Evaluation and Research
Division of General Endocrinology
5901-B Ammendale Road
Beltsville, MD 20705-1266
Phone: (301) 796-2290
Fax: (301) 595-2123
Resources For You
- Office of Cardiology, Hematology, Endocrinology and Nephrology
- 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