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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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But advisory committee members suggest narrower indication might have won their support. In recommending against approval for rheumatoid arthritis, panelist were uncertain whether imbalance in deaths in the placebo-controlled trials resulted from an artifact of trial design or a real safety signal.

Korea Should Pursue Two-Pronged Strategy In Global Vaccine Hub Bid

South Korea is making a strategic push to strengthen its vaccine capabilities, with a focus on COVID-19 and future pandemics and the aim of becoming a global development hub. But one expert told a recent meeting that these goals should not overshadow the government’s original aim of becoming self-sufficient for the national immunization program.

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