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BioPharmaceutical Regulation FDA

Drug Sponsors Mostly 'On Track' With Postmarket Study Requirements

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Executive Summary

US FDA's annual report on the status of postmarketing requirements and commitments shows 84% of open postmarket requirements for NDAs and 91% for BLAs were progressing on schedule as of Sept. 30, 2016; about half have not yet begun.

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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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