EMA Keeps Hold Of Extrapolation Template So Pharma Doesn't Lose Pediatric Focus
Executive Summary
The European Medicines Agency is sharing an “extrapolation template” with drug makers on a case-by-case basis to support complex cases of pediatric development. Despite positive feedback, the EMA is holding back from publishing the template on the grounds that companies could get bogged down in technical details and fail to address the right scientific questions.
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