Covis Pharma may be facing strong headwinds coming into the 17-19 October hearing on the future of the preterm birth prevention drug Makena (hydroxyprogesterone caproate), but it will be able to argue its case to the kind of US Food and Drug Administration advisory panel it wanted – one deep in maternal-fetal medicine experience.
Makena Hearing Panel Is Deep With Maternal-Fetal Medicine Experience, As Preferred By Covis
Of 15 voting members for the Makena advisory committee, more than half have clinical expertise in MFM or perinatology. Covis had requested that a significant proportion of the panel be practicing obstetricians with MFM specialization, while CDER sought a more balanced membership.
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