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  5. Office of Immunology and Inflammation - Division of Gastroenterology (DG)
  1. Center for Drug Evaluation and Research | CDER

Office of Immunology and Inflammation - Division of Gastroenterology (DG)


The Division of Gastroenterology (DG) regulates and reviews Investigational New Drug (IND) applications and marketing applications for drug and biologic products intended for the prevention, treatment or diagnosis of gastrointestinal conditions including: 

  • Inflammatory bowel disease
  • Irritable bowel syndrome
  • Gastroesophageal reflux disease/erosive esophagitis
  • Duodenal/Gastric ulcers
  • Celiac disease
  • Eosinophilic gastrointestinal diseases
  • Motility disorders, including gastroparesis
  • Constipation
  • Bowel cleansing agents
  • Anorectal disorders
  • Anti-diarrheal agents
  • Anti-emetics (chemotherapy-induced or postoperative nausea and vomiting)
  • Short bowel syndrome
  • Pancreatic agents

Special Procedures for Physician Requests for Domperidone

Meetings and Workshops

Rare Diseases Information

Director: Jessica J. Lee (Acting)
Deputy Director: Juli Tomaino, MD, MS
Deputy Director for Safety: Joyce Korvick

Division Director of Pharm/Tox for Immunology and Inflammation: Andrew Goodwin (Acting)

Regulatory Operations

Chief, Project Management Staff: Richard Whitehead, MS

Contact Us

Mailing Address: 

Food and Drug Administration
Center for Drug Evaluation and Research
Division of Gastroenterology
10903 New Hampshire Avenue, Silver Spring, MD 20993
Building 22, Suite 4177
Phone: (301) 796-2240
Fax: (301) 796-9838

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