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Global Harmonization Of Combination Product Regulation: EU vs US

This article was originally published in Clinica

Executive Summary

Wherever you are in the world, the regulation of many different drug/device combination products is highly complex and costly. Yet the number of products being developed in combination is soaring. In this article, Neil O'Flaherty and Roberto Cursano, partners at law firm Baker & McKenzie, review the likelihood of global regulatory harmonization in this area, focusing on the differences between the EU and the US

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