Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment Guidance for Industry
Submit Comments by 08/06/2019
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: 2019-11951
- Docket Number:
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Guidance Issuing OfficeCenter 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.