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Clinical Trials › Evidence

Davis Wright Tremaine LLP

Claims Must Be Substantiated — It Seems So Obvious, but the Who, What, Where, and How Is Not Always So Clear

Davis Wright Tremaine LLP on

When we talk about advertising claims (e.g., on product labels, websites, social, etc.), we stress that "claims must be truthful, not misleading, and substantiated." The requirements to be "truthful and not misleading" seem...more

HaystackID

[Webcast Transcript] Hatch-Waxman Matters and eDiscovery: Turbo-Charging Pharma Collections and Reviews

HaystackID on

Editor’s Note: On September 16, 2020, HaystackID shared an educational webcast designed to inform and update legal and data discovery professionals on the complexities of eDiscovery support in pharmaceutical industry matters...more

Holland & Knight LLP

FDA Issues Draft Guidance on Use of "Real-World Evidence" in Medical Device Decision-Making

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) issued on July 27, 2016, a draft guidance document addressing how it may use data and evidence collected outside of the traditional clinical trial context to support medical device...more

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