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BioPharmaceutical United States Drug Approval Standards

ANDA Approval Speed-Up Leaves Sponsors With Less Margin For Error

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Executive Summary

Get applications in right, or get a complete response letter, FDA says; firms will have fewer opportunities for mid-review application corrections as review goals reach 10 months.

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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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