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U.S. Department of Health and Human Services

About FDA

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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

 

Mission

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: 

Gastroenterology and Nutrition

  • Chemotherapy Induced or Postoperative Nausea and Vomiting
  • Inflammatory Bowel Diseases
  • Duodenal/Gastric Ulcers
  • Irritable Bowel Syndrome
  • Gastroesophageal Reflux Disease
  • Parenteral Associated Liver Disease
  • Celiac Disease
  • Eosinophilic Esophagitis
  • Short Bowel Syndrome
  • Constipation
  • Gastroparesis

  • Amino Acid Metabolism Disorders
    • Phenylketonuria (PKU)
    • Maple Syrup Urine Disease (MSUD)
    • Homocystinuria
    • Tyrosinemia
    • Urea cycle disorders (e.g., citrullinemia, arginosuccinic aciduria, ornithine transcarbamylase deficiency)
  • Lipoprotein Metabolism Disorders
    • Lecithin Cholesterol Acyltransferase (LCAT) Deficiency
  • Organic Acid Disorders (Organic Acidemias)
    • Branched chain organic acidurias
    • Glutaric academia
  • Lysosomal Storage Diseases
    • Glycogen storage diseases (e.g., Pompe disease)
    • Mucopolysaccharidoses (e.g., Hurler syndrome, Hunter syndrome, Morquio syndrome, Sanfilippo syndrome, Maroteax-Lamy syndrome, Sly syndrome)
    • Mucolipidoses
    • Oligosaccharidoses (e.g., alpha- and beta-mannosidoses, Schindler disease)
    • Lipidoses (e.g., Niemann-Pick types C and D, neuronal ceroid lipofuscinoses, lysosomal acid lipase deficiency)
    • Sphingolipidoses (e.g., Niemann-Pick type A and B, Gaucher disease, Krabbe disease, Fabry disease, GM1 and GM2 gangliosidoses, metachromatic leukodystrophy, Farber disease)
    • Lysosomal transport diseases (e.g., cystinosis)
  • Mitochondrial disorders
    • Disorders of pyruvate carboxylase and pyruvate dehydrogenase
    • Mitochondrial fatty acid oxidation disorders
  • Peroxisomal disorders
    • Peroxisomal enzyme deficiencies
    • X-linked adrenoleukodystrophy
    • Primary hyperoxaluria
  • Others
    • Hereditary Orotic Aciduria
    • Progeria

Liver Diseases

  • Fatty liver disease
  • Alcoholic liver disease
  • Liver fibrosis
  • Cirrhosis
  • Cholestatic liver diseases
  • Drug induced liver injury
  • Acute liver failure

  

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