Regulatory-grade evidence must reflect the true patient experience across care settings over time, supported by transparent, reproducible, and well-governed processes. John Snow Labs’ PJI platform ...

Recently, the U.S. Food and Drug Administration (FDA) issued a guidance document entitled Use of Real-World Evidence to Support ...

On December 15, 2025, the US Food and Drug Administration (FDA) issued a press release announcing that FDA eliminated a major ...

When it comes to regulating medical devices, the status quo of relying on premarket evidence has its limitations: it’s expensive, it’s time-consuming, and it isn’t necessarily the best data to show ...

The FDA's Center for Devices and Radiological Health has been busy over the last couple of months, releasing several draft and final guidances that affect the makers of apps and connected devices.

In today's healthcare environment, securing regulatory approval is only the beginning. The real challenge lies in ensuring ...

The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches to improve ...

Traditional clinical trial data are pseudonymized data, and these data may not contain information on a patient that directly identifies them, like a name, address, or phone number. However, ...

FDA proposes framework clinical trial designs to guide Bayesian methods, improving efficiency in drug development for rare and pediatric conditions.

For access to the publication, visit: Freeman et al. Real-World Evidence of Growth Improvement in Children 1 to 5 Years of ...