> ## 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 Complex Innovative Clinical Trial Designs
- URL: https://www.fdaweb.com/guide-on-complex-innovative-clinical-trial-designs/
- Published: 2019-09-23T12:00:00.000Z
- Updated: 2026-09-15T01:51:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145069

*Federal Register* notice: FDA has made available a draft guidance entitled “Interacting with the FDA on Complex Innovative Clinical Trial Designs for Drugs and Biological Products.” The document provides recommendations and discusses using novel trial designs, how sponsors may obtain feedback on technical issues related to modeling and simulation, and the types of quantitative and qualitative information that should be submitted for review. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-09-23/pdf/2019-20494.pdf?ref=fdaweb.com).