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U.S. Department of Health and Human Services

For Industry

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Enhancing Regulatory Science - Methodologies for Meta-Analysis

In PDUFA V, FDA agreed to a set of commitments regarding meta-analysis which refers to the combining of evidence from independent studies using appropriate statistical methods. Although many external stakeholders conduct meta-analyses, FDA’s use of meta-analyses and other safety evaluation tools has the potential to result in consequential regulatory actions, including market withdrawal or concluding that a safety concern is not supported by data.

As a result, FDA must adopt a rigorous approach to these analyses and be transparent regarding its evidentiary standards and how it weighs the evidence of a meta-analysis in arriving at a decision or regulatory action. As such, FDA’s commitments focus on best practices for the conduct of meta-analyses and FDA’s intended approach for the use of meta-analyses in regulatory decision-making.

The links below provide more information on FDA’s work in this area during PDUFA V.