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Generic Drugs FDA Regulation

ANDA Approvals May Be Hindered By New Elemental Impurities Requirements

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Executive Summary

US FDA's generic approval total in January was dramatically lower than recent monthly tallies, raising questions about impact of requirements that took effect at beginning of the year.

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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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