> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Nonalcoholic Steatohepatitis Drug Development Guide
- URL: https://www.fdaweb.com/nonalcoholic-steatohepatitis-drug-development-guide/
- Published: 2019-06-07T12:00:00.000Z
- Updated: 2026-09-15T01:31:30.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144284

*Federal Register* notice: FDA has made available a draft guidance entitled “Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment.” The document provides the agency’s current recommendations on important components of a drug development program for treating this condition. It focuses on enrollment criteria, trial design, efficacy endpoints, and safety considerations for Phase 3 trials. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-06-07/pdf/2019-11951.pdf?ref=fdaweb.com).