Regulatory Science Accelerator
Computational Modeling & Simulation in FDA-Regulated Products 

GSP ReportThe Regulatory Science Accelerator (RSA) creates collaboration space for academics, researchers, and other experts to share information on emerging technology relevant to FDA. Developed by the Foundation in partnership with FDA's Office of the Chief Scientist's Office of Regulatory Science and Innovation, the Accelerator helps address the strategic priorities named in the "Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science" report.

The RSA represents opportunities for FDA to efficiently prepare for new science and technology that Agency staff will likely encounter in its regulatory work. In addition, RSA activities can positively influence the way science is conducted in the focus areas of regulatory science by stakeholders in the FDA-regulated ecosystem. Outcomes from that science (applied and translational) can be efficiently vetted by FDA (i.e., qualified) and more readily implemented into the regulatory review process with minimal delay, while improving the quality and integrity of FDA’s regulatory decisions.  

In Silico ReportThe RSA is intended to provide additional insight in three key areas:  

  • emerging science and technology that centers need to provide future regulatory review
  • the opportunities and pitfalls associated with new science and technologies  
  • exploring potential next steps to meet the anticipated regulatory science to help speed innovation

Guided by the 2022 update to the "Advancing Regulatory Science at the FDA: Focus Areas of Regulatory Science" report, the ORSI/Foundation collaboration identified two cross-cutting issues stemming from the FARS report warranting continued investment. The RSA then convened expert clusters (working groups) focused on In Silico Alternative Methods and Good Simulation Practice. Read those reports by clicking the images on the right.