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BioPharmaceutical United States Drug Approval Standards

Drug Shortage Prevention Could Be Funded Through GDUFA

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Executive Summary

GPhA recommends FDA deploy user fee research money to look at shortage risk assessment and mitigation strategies, while the trade group continues to look for a product to fit its own shortage prediction model.

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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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