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GUIDANCE DOCUMENT

Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets May 2013

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2011-D-0057
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance describes best practices pertaining to conducting and reporting on pharmacoepidemiologic safety studies2 that use electronic healthcare data, which include administrative claims data and electronic medical record (EMR) data.3 The guidance includes recommendations for documenting the design, analysis, and results of pharmacoepidemiologic safety studies to optimize FDA’s review of protocols and final reports that are submitted to the Agency. For purposes of this guidance, the term pharmacoepidemiologic safety study refers to an observational study designed to assess the risk associated with a drug exposure and to test prespecified hypotheses. For ease of reference, this guidance uses the term drug to refer to drug and biological products regulated by CDER or CBER. Medical devices are not within the scope of this guidance.

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All written comments should be identified with this document's docket number: FDA-2011-D-0057.

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