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  6. Office of Cardiology, Hematology, Endocrinology and Nephrology - Division of General Endocrinology (DGE)
  1. CDER Offices and Divisions

Office of Cardiology, Hematology, Endocrinology and Nephrology - Division of General Endocrinology (DGE)

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:

  • Acromegaly
  • 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
  • Cachexia
  • Hypo- and hyperthryoidism
  • Hyperparathyroidism
  • Developmental disorders (accelerated or delayed puberty)
  • Cushings sundrome
  • Geriatric frailty and sarcopenia
  • Lipodystrophy
  • Vitamin deficiency (except vitamin D)

Contact Us

Mailing Address:

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

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