Successes and Opportunities in Modeling & Simulation for FDA

The US FDA has shared a document illustrating when and how simulations and models are already useful to approach the approval process... when will EU and the Member States provide an equivalent document? Let's all remember that European communities (Physiome Project, Virtual Physiological Human, Virtual Patient, Human Brain Project, ...) have been pioneering models and simulation for healthcare since the very early days, with great investments and commensurate achievements! We cannot fall behind now that we have to anchor practices to the ground...

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

    Elucidates how and where models and simulations is used across FDA, and the type and purpose of models and simulations used

    Presents a selection of models and simulations case studies from across nearly all FDA centers, which demonstrate how models and simulations is playing a tangible role in FDA fulfilling its mission

    Identifies opportunities for FDA to better harness models and simulations in upcoming years by embracing computational advances and new (and big) data streams to develop improved public health solutions