FDAnews Drug Daily Bulletin
Pharmaceuticals / Research and Development

EMA Outlines Use of Data Extrapolation in Pediatric Applications

Oct. 19, 2017
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The European Medicines Agency outlined its thoughts on the use of evidence generated through extrapolation techniques in regulatory assessments, in a draft reflection paper.

The paper aims to provide a framework for the quantitative methods needed to evaluate the relevance of existing clinical information in new, untested target populations, including pediatrics.

A specific extrapolation plan, the EMA said, can address the knowledge gaps inherent in making predictions for how a drug will perform in a new population — and can help allow the “totality of evidence” answer the scientific questions under a marketing authorization.

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