“We’re in a global market. We need to stop being parochial and work globally from the beginning.”
Sarah Meibusch, principal at Oneventures, during a panel discussion at the AusBiotech meeting

“This meeting has made me aware of the limitations of the data that we are actually working with.”
Thomas Ortel, chief of the Division of Hematology at Duke University, during a meeting of the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee, which voted 14-1, with one abstention, that contraceptive patch Twirla’s benefits outweigh its risks, despite overwhelmingly negative briefing documents from agency reviewers

“Mothers and babies shouldn’t have to rely on luck. We need data.”
Annie Ellis, patient representative and member of the FDA’s advisory committee, which voted 9-7 to recommend preterm birth drug Makena be removed from the market

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