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Drug Approval Standards Rare Diseases FDA

Can The FDA Climate Be Too Good?

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Executive Summary

US FDA’s decision to accept Amicus’ migalastat NDA without a new study is the latest sign of the positive climate for rare disease drugs at FDA. But will it be remembered as a turning point?

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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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