EFPIA Picks Holes In EMA's Pediatric Extrapolation Proposals
Pharmaceutical companies are worried about new requirements the European Medicines Agency has proposed on using extrapolation to support the development of pediatric medicines.
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Modeling and simulation approaches are expected to play even a greater role in regulatory decision-making by the European Medicines Agency in the coming years.
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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