Successes and Opportunities in Modeling & Simulation at FDA

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:

  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

For more information, download the full report

Date: 28/11/2022 | Tag: | News: 1384 of 1588
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