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FDA Issues Draft Guidance Encouraging More Widespread Use of Electronic Health Record Data in Clinical Trials

By Amy K. Dow on May 17, 2016
Posted in FDA, Health Information Technology, Life Sciences, Medical Device, Pharmaceuticals

On May 17, 2016, FDA issued Draft Guidance for Industry on Use of Electronic Health Record Data in Clinical Investigations (“Draft Guidance”).  This Draft Guidance builds on prior FDA guidance on Computerized Systems Used in Clinical Investigations and Electronic Source Data in Clinical Investigations, and provides information on FDA’s expectations for the use of…

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