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Advisory Committees Post Market Regulation & Studies Review Pathway

Makena Withdrawal Dilemma: Advisory Cmte. Split Offers No Clear Direction For US FDA

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Executive Summary

Nine of 16 advisory committee members favored withdrawal of AMAG’s preterm birth drug because substantial evidence of efficacy is lacking and clinical benefit has not been confirmed; seven panelists favored keeping the drug on the market but requiring a new trial.

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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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