Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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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.
Makena’s Accelerated Approval Will Hang In Balance At US FDA Panel Meeting In October
Advisory committee will re-evaluate the continued marketing of AMAG Pharmaceuticals’ preterm birth drug after a failed confirmatory study; the last time an advisory committee weighed in on the future of an accelerated approval drug was for Avastin's breast cancer claim.
Vascepa Advisory Committee Is Latest Outpost In Product's Remarkable Regulatory Journey
The last time representatives from Amarin and US FDA formally met in public, it was in court.