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FDA Provides Guidance on Use of Electronic Health Data, Pooled Data in Postmarketing Studies

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A new guidance document released by US federal regulators aims to establish best practices for conducting and reporting pharmacoepidemiologic safety studies that are conducted using electronic Read More...

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Clinical Trials

EHR

Electronic Health Data

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Pooled Data

FDA, Data Standard Groups Promote Adoption of EHRs

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The US Food and Drug Administration (FDA), the US Department of Health and Human Services' (DHHS) Office of the National Coordinator for Health Technology (ONC) and the Clinical Data Interchange Read More...

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CDISC

Clinical Data

Clinical Trials

DHHS

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Electronic Health Records

FDA

ONS

Woodcock: Electronic Health Records Key To Helping Regulatory Professionals

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Janet Woodcock, Director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), told a pharmaceutical conference this week that electronic health records are Read More...

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CDER

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Electronic Health Records

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Woodcock

RF Today is Regulatory Focus' daily news brief. Each edition contains the top global regulatory news stories about pharmaceuticals, medical devices, biotechnology and more. Learn more

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FDA Provides Guidance on Use of Electronic Health Data, Pooled Data in Postmarketing Studies

FDA, Data Standard Groups Promote Adoption of EHRs

Woodcock: Electronic Health Records Key To Helping Regulatory Professionals

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