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BioPharmaceutical United States Legislation

FDA Shortage Notification Mandate May Not Extend To Biologics

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Executive Summary

The agency has the option to issue regulations requiring biologics manufacturers to notify FDA of emerging production problems, but so far it’s only “something that we’re thinking about.”

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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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