> ## 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.

# FDA Modeling, Simulation Successes
- URL: https://www.fdaweb.com/fda-modeling-simulation-successes/
- Published: 2022-11-22T12:00:00.000Z
- Updated: 2026-09-14T18:07:20.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5153252

The FDA Modeling and Simulation (M&S) Working Group, created in 2016 by the agency’s Office of the Chief Scientist, has issued a report on how M&S is used across and within FDA Centers and the impact it has had on the agency’s mission to protect public health. The [report’s](https://www.fda.gov/media/163156/download?ref=fdaweb.com) three primary aims were to:

- elucidate how and where M&S is used across FDA and the type and purpose of M&S used;
- present a selection of M&S case studies from across the Centers to demonstrate how M&S is playing a tangible role in FDA fulfilling its mission; and
- identify opportunities for FDA to better harness M&S in upcoming years by embracing computational advances and new (and big) data streams to develop improved public health solutions.

The report says that M&S are powerful tools that complement traditional methods of gathering evidence about regulated products. It says agency scientists routinely review results from M&S studies submitted by industry and use M&S approaches for scientific research and regulatory decision-making.

“In the last decade,” FDA says, “M&S has become firmly established as a regulatory science priority at FDA, which has coincided with the explosive growth in data science and model-based technologies.”