FDA DRAFT GUIDANCE: Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies Guidance for Industry

In recent years, the US Congress and the US Food and Drug Administration (FDA) have emphasized the importance of including underrepresented populations in clinical trials. This push for diversity is not just a regulatory requirement but a critical step towards … Read More

In Silico Technologies: A Strategic Imperative for Accelerating Breakthroughs and Market Leadership for FDA-Regulated Products

InSilicoTrials recently collaborated with a team of experts led by Tina M. Morrison on a significant initiative supported by the FDA and the U.S. Department of Health and Human Services. The project, titled “A Strategic Imperative for Accelerating Breakthroughs and … Read More

FDA releases guidance for dose optimization in oncology trials

Following the 2021 launch of Project Optimus by the Oncology Center of Excellence and an extensive workshop on the topic, in January 2023 the FDA released a draft guidance for industry entitled “Optimizing the Dosage of Human Prescription Drugs and … Read More

Successes and Opportunities in Modeling & Simulation for FDA

The use of in silico trials is expected to play an increasingly important role in the development and regulatory evaluation of new drugs and medical devices. One of the advantages that in silico approaches offer is the possibility to test … Read More

Simulation to help fight cardiovascular disease

Simulation to help fight cardiovascular disease. As we all know, cardiovascular disease (CVD) is the leading cause of death worldwide, with 18 million deaths each year according to WHO estimates. Currently, 15 million people in Europe live with heart failure. You can see why we were so … Read More

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