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# Guidance on Drug Complex Innovative Trial Designs
- URL: https://www.fdaweb.com/guidance-on-drug-complex-innovative-trial-designs/
- Published: 2020-12-17T12:00:00.000Z
- Updated: 2026-09-14T16:40:38.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148332

*Federal Register* notice: FDA has made available a final guidance entitled *Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products*. The document discusses the use of novel trial designs in the development and regulatory review of drugs and biological products, 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-2020-12-17/pdf/2020-27813.pdf?ref=fdaweb.com).