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# Draft Guide on Noncirrhotic Nonalcoholic Steatohepatitis
- URL: https://www.fdaweb.com/draft-guide-on-noncirrhotic-nonalcoholic-steatohepatitis/
- Published: 2018-12-03T12:00:00.000Z
- Updated: 2026-09-15T00:48:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142941

FDA has released a [draft guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM627376.pdf?ref=fdaweb.com) entitled “Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment.” The document is intended to assist sponsors by describing the agency’s current thinking about the necessary components of a drug development program for such conditions. It identifies knowledge gaps that represent important challenges in developing such drugs. The guidance does not address the clinical development of drugs for treating cirrhosis caused by nonalcoholic steatohepatitis. It also does not address the clinical development of *in vitro* diagnostic devices that may assist in drug development.