Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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The Bone, Reproductive and Urologic Drugs Advisory Committee voted 14-1, with one abstention, in favor of approving Agile's transdermal contraceptive patch Twirla in a sharp divergence from the US FDA's negative evaluation of the drug, though it remains an open question of how the agency will ultimately come down.
Makena Withdrawal Dilemma: Advisory Cmte. Split Offers No Clear Direction For US FDA
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.
AMAG’s Explanation For Makena's Failed Confirmatory Trial Faces Skeptical US FDA
Post hoc analyses show no convincing evidence that PROLONG trial's failure to meet its coprimary efficacy endpoints stemmed from baseline risk differences in subjects compared to an earlier trial, agency says; advisory committee is being asked whether to withdraw accelerated approval or keep the drug on the market, with or without a new confirmatory study.