In November 2022, the Modeling & Simulation Working Group of the FDA released a report of great importance for the in silico medicine community!
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 the Food and Drug Administration (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.
In 2016, FDA’s Office of the Chief Scientist approved the formation of the Modeling and Simulation Working Group (ModSimWG) with the main goal of supporting the implementation of M&S in the regulatory review process.
The Working Group
developed this report, which, describes the role and impact of M&S across the Agency.
There are three main aims of this report:
For more information, download the full report