Articles and Insights About Wearables for Clinical Trials

FDA & Regulations

Essential Steps to FDA Approval for Digital Biomarkers [Infographic]

 Kate Lyden, PhD

The FDA is working toward modernizing its framework for advancing the promise of digital health tools. Scientists and researchers can be creative and innovative using real-world data collected from wearable sensors and connected technologies. The key is to demonstrate well-defined practices to demonstrate sufficient data quality and fidelity to provide evidence in regulatory decision-making.

In this infographic, we outline the essential steps required to get FDA approval for digital biomarkers.

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Experts Discuss Novel Evidence for Regulatory Decisions at #scope2023

 Dan Chupka

#scope2023 is living up to its mission of driving innovation in clinical trials. Here are a few key takeaways that stood out from the expert panel at the Novel Evidence for Regulatory Success breakout session.

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