U.S. flag An official website of the United States government
  1. Home
  2. About FDA
  3. FDA Organization
  4. Center for Drug Evaluation and Research | CDER
  5. FDA Office Division of Metabolism and Endocrinology Products (DMEP)
  1. Center for Drug Evaluation and Research | CDER

FDA Office Division of Metabolism and Endocrinology Products (DMEP)


The Office of New Drugs is undergoing a reorganization. This site will 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. Until this page is updated, please contact druginfo@fda.hhs.gov or newdrugstransitionteam@fda.hhs.gov for updates and additional information.

Director: Lisa Yanoff, M.D. (acting)
Deputy Director:  John Sharretts, M.D. (acting)
Deputy Director for Safety: Anil Rajpal, M.D. (acting)
Chiefs, Project Management Staff: Julie Van der Waag, Pamela Lucarelli
Safety Regulatory Project Manager: Marissa Petrucelli
Associate Director for Labeling: Monika Houston
Associate Director for Therapeutics:  Patrick Archdeacon, M.D. (acting)
Pharm/Tox Supervisors: Todd Bourcier, Ph.D.; C. Lee Elmore, Ph.D
Administrative Officer: Nicole Cooper
Project Specialist: Lena Staunton
Project Specialist: Adanma Oji 


The Division of Metabolism and Endocrinology Products (DMEP) 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:

  • Type 1 and Type 2 diabetes mellitus, including insulins and glucagons
  • Weight loss and weight maintenance
  • 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 
  • Hypercholesterolemia
  • Adrenal and ACTH disorders
  • Anabolic steroids
  • Cachexia
  • Hypo- and hyperthryoidism
  • Hyperparathyroidism
  • Developmental disorders (accelerated or delayed puberty)
  • Cushings sundrome
  • Geriatric frailty and sarcopenia
  • Lipodystrophy
  • Vasopressins (central diabetes insipidus, noctural enuresis)
  • Vitamin deficiency (except vitamin D) 
Mailing Address:
Food and Drug Administration
Center for Drug Evaluation and Research
Division of Metabolism and Endocrinology Products
5901-B Ammendale Road
Beltsville, MD 20705-1266
Phone: (301) 796-2290
Fax: (301) 595-2123

 

ResourcesForYou