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Overhauling oversight—European drug legislation

At the end of next month, the European Medicines Agency (EMEA) will implement a new legislative framework and several provisions that seek to provide incentives and streamline regulatory oversight of certain monoclonal antibodies and other biologic products.

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I would like to thank Donald Beers for help in the preparation of this article.

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Tsang, L. Overhauling oversight—European drug legislation. Nat Biotechnol 23, 1050–1053 (2005).

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