Guide on Trial Data Sets for NASH Drugs

FDA has released a guidance entitled Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH). The document provides detailed information and specifications for the content of the tabulated domains and analysis data sets submitted to FDA as part of a sponsor’s application for drugs intended to treat noncirrhotic NASH. It does not provide recommendations for clinical development of such drugs, or assessment of potential drug-induced liver injury. “The recommendations outlined in the guidance pertain to submission of the sponsor’s tabulated and analysis data sets in order to improve reviewability,” the agency says. These specifications also provide an opportunity for dialog between the sponsor and CDER Division of Hepatology and Nutrition to discuss issues related to trial design or conduct that may affect the content of these data sets.