> ## 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.

# Guide on Technical Specs for NASH Drug Data Sets
- URL: https://www.fdaweb.com/guide-on-technical-specs-for-nash-drug-data-sets/
- Published: 2022-01-21T12:00:00.000Z
- Updated: 2026-09-14T17:29:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150975

FDA has release a revised 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 the sponsor’s NDA for such products. It is intended to improve the reviewability of the submission, the agency says, adding that it does not provide recommendations for clinical development of NASH drugs. “These specifications also provide an opportunity for dialog between the sponsor and reviewers to discuss issues related to trial design or conduct that may affect the content of these data sets," the [guidance says](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/technical-specifications-submitting-clinical-trial-data-sets-treatment-noncirrhotic-nonalcoholic?ref=fdaweb.com).