Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH)

On 31 August 2021 the FDA published the final guidance on technical specifications document for industry.

Nonalcoholic steatohepatitis (NASH) is a subcategory of nonalcoholic fatty liver disease (NAFLD). NASH carries a significant disease burden as it can progress to cirrhosis and liver failure and is associated with an increase incidence of liver cancer. Currently, the U.S. Food and Drug Administration (FDA) has not approved any therapies for NASH.

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