Tag: RWD

RWD

Regulatory/FDA

Comment Now on FDA Draft Guidance on Use of EHR, Claims Data as RWD

Comment Now on FDA Draft Guidance on Use of EHR, Claims Data as RWD

Oct. 4, 2021 – As part of its real-world evidence (RWE) program, the Food and Drug Administration last week issued a draft guidance to provide sponsors, researchers and other stakeholders with the agency’s current thinking about the use of electronic health records (EHRs) or medical claims data in clinical studies “to support a regulatory decision […]

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CHC News

Guest Commentary: Exploring a New Frontier in Healthcare

Guest Commentary: Exploring a New Frontier in Healthcare

June 26, 2018 — By Michael Parenti, Senior Engagement Strategist, Saatchi & Saatchi Wellness Real world evidence and data privacy regulations were among the hot topics at the Coalition for Healthcare Communication 2018 Rising Leaders Conference on Healthcare Policy. A source of much corporate concern, the European Union’s General Data Protection Regulation (GDPR) finally went […]

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