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BioPharmaceutical

HRA’s Efficient Ella Development Strategy Begat FDA’s Efficient NDA Review

This article was originally published in Pharmaceutical Approvals Monthly

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Executive Summary

The story of HRA Pharma’s emergency contraceptive Ella (ulipristal) bears many of the hallmarks of what many sponsors would consider a desirable regulatory path, culminating in a first-cycle approval with clean labeling.
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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