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Nature Reviews Drug Discovery 7, 459 (1 June 2008) | doi:10.1038/nrd2612
In this issue
Abstract
Legislation to create a regulatory pathway for follow-on biologics, currently under consideration by the US Congress, raises scientific, regulatory and legal issues. In this month's perspective, Grabowski emphasizes the importance of appropriate data exclusivity periods for new biological entities within this legislation to allow innovator companies to achieve a return on their R&D investments.
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