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
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 In December 2018, FDA issued a draft guidance outlining recommendations for clinical development of drugs intended for treatment of noncirrhotic NASH with liver fibrosis. The 2018 draft guidance for industry acknowledges that subjects with NASH fibrosis have unique challenges (e.g., underlying hepatic dysfunction) during drug development.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. The recommendations outlined in the guidance pertain to submission of the sponsor’s tabulated and analysis data sets in order to improve reviewability. These specifications also provide an opportunity for dialogue between the sponsor and DHN to discuss issues related to trial design or conduct that may affect the content of these data sets. These specifications are intended to support the draft guidance for industry Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment (NASH Guidance) and reflect the data standards and processes described in the FDA Study Data Technical Conformance Guide.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)