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GUIDANCE DOCUMENT

Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH) Guidance for Industry Technical Specifications Document January 2022

Download the Final Guidance Document
Final Level 2 Guidance
Docket Number:
FDA-2018-D-1216
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-1216.

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