Division of Gastroenterology and Inborn Errors Products (DGIEP)

Director: Donna Griebel, M.D.
Deputy Director: Andrew E. Mulberg, M.D., FAAP, CPI
Deputy Director for Safety: Joyce Korvick, M.D.

Chiefs, Project Management Staff: Brian Strongin and Richard (Wes) Ishihara

 

The Division of Gastroenterology and Inborn Errors Products (DGEIP) regulates Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Biologics Licensing Applications (BLAs) for drugs and biologics intended for the prevention and treatment of gastrointestinal conditions and inborn errors of metabolism including: 

• Chemotherapy Induced or Postoperative Nausea and Vomiting
• Crohn’s Disease
• Duodenal/Gastric Ulcers
• Fabry’s Disease
• Gastroesophageal Reflux Disease
• Gaucher’s Disease
• Irritable Bowel Syndrome
• Ulcerative Colitis

  

Mailing Address:
Food and Drug Administration
Center for Drug Evaluation and Research
Division of Gastroenterology and Inborn Errors Products
5901-B Ammendale Road
Beltsville, MD 20705-1266
Phone: (301) 796-2120
Fax: (301) 796-9904