Post-approval evidence generation is essential for high-quality clinical care and should be a shared priority for clinicians, health systems, payors, and the medical products industry, as well as the ...

Over the past decade, about one-fifth of FDA-approved drugs each year involve novel mechanism-of-action human targets. Although riskier than modulating well-known targets, these therapies address ...

The US Food and Drug Administration (FDA) is offering a detailed look at how real-world evidence sources – from registries to claims data – can be used to support marketing applications for medical ...