Technical specifications for submitting clinical trial data sets for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH)
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Drug Evaluation and Research (U.S.), issuing body.
- Publication:
- [Silver Spring, MD] : Center for Drug Evaluation and Research, January 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Clinical Trials as Topic Non-alcoholic Fatty Liver Disease -- drug therapy United States United States. Department of Health and Human Services United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- 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. The Division of Hepatology and Nutrition (DHN) serves as the clinical review division in the Office of New Drugs (OND) for review of drug products for treatment of liver fibrosis due to NASH. In December 2018, FDA issued a draft guidance outlining recommendations for clinical development of drugs intended for treatment of noncirrhotic NASH with liver fibrosis. The 2018 draft guidance for industry acknowledges that subjects with NASH fibrosis have unique challenges (e.g., underlying hepatic dysfunction) during drug development. Furthermore, evaluation of potential drug-induced liver injury (DILI) in this population is challenging because the risk of DILI in subjects with underlying liver disease has not been fully characterized and it can be difficult to differentiate between progression of liver disease and DILI. This document provides detailed information and specifications for the content of the tabulated domains and analysis data sets submitted to FDA as part of the sponsor’s/applicant’s application for drugs intended to treat noncirrhotic NASH. This guidance does not provide recommendations for clinical development of drugs intended for treatment of NASH, or assessment of potential DILI.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (41 pages)).
- NLM Unique ID:
- 9918351277606676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918351277606676