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GUIDANCE DOCUMENT

Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment Guidance for Industry June 2019

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Docket Number:
FDA-2019-D-1516
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the  treatment of nonalcoholic steatohepatitis (NASH) with compensated cirrhosis. 

This guidance describes the Food and Drug Administration’s (FDA’s) current recommendations  regarding the important components of a drug development program for compensated NASH  cirrhosis. This guidance focuses on the enrollment criteria, trial design, efficacy endpoints, and safety considerations for phase 3 trials. This guidance also identifies knowledge gaps that  represent important challenges in the development of drugs for this indication.


Submit Comments

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

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-1516.