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FDA Releases Draft Guidance On Digital Health Technologies For Remote Data Acquisition In Clinical Investigations

In response to COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) continues to work in support of clinical investigation sponsors and an evolving environment in which they run their clinical trials while...more

Is 2021 The Value-Based And Shared Savings Revolution?

By now you are likely aware of the new safe harbor provisions of the federal anti-kickback statute (AKS), which the U.S. Office of Inspector General (OIG) finalized as of January 19, 2021. Among other changes to the AKS...more

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