The FDA now accepts RWE for device submissions without needing identifiable patient data, facilitating the use of large, de-identified databases. This change addresses previous limitations that ...

The legal and regulatory commentary on the FDA's December 2025 final guidance on real-world evidence (RWE) for medical ...

Pharma and biotech companies have access to an unprecedented variety of health data, from electronic health records and medical or pharmacy claims to genomic, behavioral and sensor data. Yet it can be ...

Real-World Data (RWD) has become one of the most widely discussed topics across the global medtech sector. But what is driving this increased attention? In reality, collecting data from clinicians and ...

Real-world evidence (RWE) has emerged as a vital complement to traditional randomised controlled trials by capturing the effectiveness and safety of interventions in routine clinical practice. Drawing ...

MEDDDICAL has launched a real-world evidence analytics and advisory service, offering structured guidance to pharmaceutical and MedTech companies at a time when real-world evidence requirements from ...

Carelon Research, a subsidiary of Elevance Health, and Manifold, an enterprise agent platform for life sciences, today announced a strategic partnership that gives life sciences researchers and data ...

Real-world evidence (RWE) has become a crucial driver of the pharmaceutical and biotechnology industries in recent years. In fact, RWE is now included in 70 percent of new drug and biologic regulatory ...

Why is tokenization important for the future of medicine development? A tremendous amount of data is collected throughout a clinical trial, but prior to tokenization, the life science industry did not ...

Inovalon, a leading provider of data and solutions empowering data-driven healthcare, and OMNY Health, a leading healthcare ecosystem for compliant real-world data (RWD) insights at scale, today ...