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  1. CDER Offices and Divisions

Office of Immunology and Inflammation - Division of Hepatology and Nutrition (DHN)

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

Liver Diseases and Nutrition

  • Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly referred to as nonalcoholic fatty liver disease (NAFLD) and metabolic dysfunction-associated steatohepatitis (MASH), formerly referred to as 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
  • Parenteral nutrition products:
    • Intravenous fluids
    • Intravenous Eelectrolytes, vitamins, trace elements
    • Dextrose solutions, amino acid solutions, intravenous lipid emulsions

MASH/NASH Guidance Documents:

Meetings and Workshops

Rare Diseases Information

Contact Us

Mailing Address: 

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

Resources 



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