Tag: RWE

RWE

Regulatory/FDA

Myers: Data Will Drive Califf’s Decisions at FDA

Myers: Data Will Drive Califf’s Decisions at FDA

March 14, 2021 – Nearly a month after being sworn in for the second time as Food and Drug Administration (FDA) Commissioner, Robert Califf, M.D., has a lot on his plate, including the ongoing COVID-19 pandemic — and lessons learned about processes and the harms of misinformation – as well as a call for clinical […]

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Comment Now on FDA Draft Guidance on Use of EHR, Claims Data as RWD

Comment Now on FDA Draft Guidance on Use of EHR, Claims Data as RWD

Oct. 4, 2021 – As part of its real-world evidence (RWE) program, the Food and Drug Administration last week issued a draft guidance to provide sponsors, researchers and other stakeholders with the agency’s current thinking about the use of electronic health records (EHRs) or medical claims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