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          Modeling & Simulation at FDAAbout Science & Research at FDA Modeling & Simulation at FDA
  
  					FDA scientists routinely use M&S approaches for scientific research and regulatory decision-making
	
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              Successes and Opportunities in Modeling and Simulation for FDAOn 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:

Elucidates how and where M&S is used across FDA, and the type and purpose of M&S used
	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
	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 solutionsView 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.

Related Links

Advancing Alternative Methods at FDA
	Focus Areas of Regulatory Science Report

                                                                                  Content current as of:
      11/16/2022
              
              
Topic(s)
			  ResearchAbout Science & Research at FDA

          
                        Emerging Sciences
          Public Access to Results of FDA-Funded Scientific Research
          Scientific Integrity at FDA
          FDA Sexual Harassment Policy Concerning Extramural Research
          Medical Product Development Tools at FDA
          Modeling & Simulation
          FDA's Predictive Toxicology Roadmap


                        Advancing Alternative Methods at FDA
          FDA Grand Rounds
          The FDA Science Forum
 
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