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Flawed GVK studies: EMA sticks with suspension as Indian CRO fights on

This article was originally published in SRA

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Executive Summary

There is no respite for GVK Biosciences, the Indian contract research organization in the eye of a storm over allegations of data manipulation by European regulators. The European Medicines Agency said today it was sticking with its previous recommendation to suspend a large number of drugs whose approvals in the EU were primarily based on clinical studies conducted at GVK's Hyderabad unit1,2. GVK for its part said it would continue to fight its case.

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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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