25 October 2022 -  Last week’s overwhelming vote in favour of pulling preterm-birth drug Makena from the market — and the advisory committee’s commentary before the 14-1 tally was taken — backed up concerns that keeping the injectable available to patients could undermine the FDA’s accelerated approval process.

“I think it is important for us to make sure that we avoid going down the pathway that will cause regulatory chaos,” said advisory committee member Mark Hudak of the University of Florida College of Medicine in Jacksonville. “I think that the accelerated approval has very clear expectations and these were not met.”

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