Optimizing Pediatric Medicine Developments in the European Union Through Pragmatic Approaches.

Clin Pharmacol Ther · 2021 · PMC8518420 · PMID 33411346

Europe PMC DOI

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quite significantno p-value reported

The additional administrative burden on regulators and sponsors is quite significant and challenging to handle and the current operational implementation of Article 46 by the EMA has not been reported to have had any additional impact on public health.

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