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  6. Division of Gastroenterology and Inborn Errors Products (DGIEP)
  1. Office of Medical Products and Tobacco

Division of Gastroenterology and Inborn Errors Products (DGIEP)


Director (Acting): Dragos Roman, M.D.
Deputy Director (Acting): Bindi Nikhar, M.D.
Deputy Director for Safety: Joyce Korvick, M.D., MPH
Associate Director: Jessica J. Lee, M.D., MMSc
Associate Director: Lisa Soule, M.D.

Chiefs, Project Management Staff:
CDR Renmeet Grewal, Pharm.D., MS, RAC
Jacqueline Lee Hoffman, Pharm.D. (Acting)

Mission

The Division of Gastroenterology and Inborn Errors Products (DGIEP) 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, hepatic, and nutritional disorders and inborn errors of metabolism including: 

Gastroenterology

  • 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

 

Inborn Errors of Metabolism

  • Amino Acid Metabolism Disorders
    • Phenylketonuria (PKU)
    • Maple Syrup Urine Disease (MSUD)
    • Homocystinuria
    • Tyrosinemia
    • Urea cycle disorders (e.g., citrullinemia, argininosuccinic aciduria, ornithine transcarbamylase deficiency)
  • Lipoprotein Metabolism Disorders
    • Lecithin Cholesterol Acyltransferase (LCAT) Deficiency
  • Organic Acid Disorders (Organic Acidemias)
    • Propionic acidemia
    • Methylmalonic acidemia
    • Glutaric acidemia
  • Lysosomal Storage Diseases
    • Glycogen storage diseases (e.g., Pompe disease)
    • Mucopolysaccharidoses (e.g., Hurler syndrome, Hunter syndrome, Sanfilippo syndrome Morquio 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 complex
    • Leigh syndrome
    • Barth syndrome
    • Disorders of mitochondrial depletion
    • Mitochondrial fatty acid oxidation disorders
    • Primary carnitine deficiency
  • Peroxisomal disorders
    • Peroxisomal enzyme deficiencies
    • X-linked adrenoleukodystrophy
  • Bile acid synthesis disorders
    • Cerebrotendinous Xanthomatosis
  • Others
    • Hereditary Orotic Aciduria
    • Progeria
    • Menkes syndrome
    • Cockayne syndrome
    • Congenital disorders of glycosylation
    • Hypophosphatasia
    • Cerebral creatine deficiency syndromes

 

Liver Diseases and Nutrition

  • Nonalcoholic fatty liver disease (NAFLD) including nonalcoholic steatohepatitis (NASH)
  • Alcohol Associated liver disease, including Alcohol Associated Acute Hepatitis
  • Liver fibrosis, including liver fibrosis secondary to viral liver diseases such as Hepatitis C, B
  • Cirrhosis
  • Portal hypertension
    • Hepatic encephalopathy
    • Varices and variceal bleeding
    • Ascites secondary to portal hypertension
  • Wilson’s disease
  • Autoimmune Hepatitis (AIH)
  • Drug induced liver injury
  • Polycystic Liver Disease
  • Acute liver failure
    • Acute liver failure associated with Amanita mushroom poisoning
    • Liver failure associated with acetaminophen toxicity
  • Acute-on-chronic liver failure (ACLF)
  • Liver failure associated with parenteral nutrition
  • Alpha 1 antitrypsin associated liver disease
  • Lipodystrophy associated liver disease
  • Bile Acid Malabsorption
  • Cholestatic liver diseases
    • Primary biliary cholangitis
    • Primary sclerosing cholangitis
    • Progressive familial intrahepatic cholestasis (PFIC) including Byler disease
    • Inborn errors of bile acid metabolism
    • Alagille syndrome
    • Biliary atresia
  • Parenteral Nutrition Associated Liver disease / Intestinal Failure Associated Liver Disease