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  1. About Science & Research at FDA

Modeling & Simulation at FDA

FDA scientists routinely use M&S approaches for scientific research and regulatory decision-making

Successes and Opportunities in Modeling and Simulation for FDA

On this page: About M&S | FDA M&S Working Group | Report on Successes and Opportunities | Contact FDA | Related links  

About Modeling & Simulation (M&S)

Computational (in silico) modeling and simulation (M&S) are powerful tools that complement traditional methods for gathering evidence–including bench-top (in vitro) testing, and animal or clinical (in vivo) studies–about products regulated by FDA or for developing FDA policy. 

FDA 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, 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.

FDA Modeling & Simulation Working Group

FDA’s Office of the Chief Scientist formed the Modeling and Simulation Working Group in 2016. The group includes nearly 200 FDA scientists who are supporting the implementation of M&S in the regulatory review process across FDA, among other goals. 

Report on Successes and Opportunities

In November 2022, FDA published a new report, Successes and Opportunities in Modeling & Simulation for FDA. The report:

  1. Elucidates how and where M&S is used across FDA, and the type and purpose of M&S used
  2. Presents a selection of M&S case studies from across nearly all FDA centers, which demonstrate how M&S is playing a tangible role in FDA fulfilling its mission
  3. Identifies 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

View the report (PDF, 839 KB)

Contact FDA

Contact the corresponding authors with questions about this report.

Contact ModSimWG leadership with general questions about modeling and simulation at FDA.

Press/media: Contact FDA’s Office of Media Affairs at fdaoma@fda.hhs.gov or call 301-796-4540.

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