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Advisory Committees Post Market Regulation & Studies Review Pathway

AMAG’s Makena: Did Accelerated Approval Kill The Confirmatory Trial?

  • Analysis

Executive Summary

Sponsor’s assertion that recruitment of high-risk, US patients was negatively impacted by the preterm birth drug’s availability under accelerated approval led some advisory committee members to opine that Makena came to market too soon; the experience could make the FDA more cautious about granting accelerated approval unless confirmatory studies are at an advanced stage.

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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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