Withdrawing Approval of Makena — A Proposal from the FDA Center for Drug Evaluation and Research
Christina Y. Chang, Christine Nguyen, Barbara Wesley, Jia Guo, Laura Lee Johnson, Hylton V. Joffe
Abstract
Withdrawing Approval of Makena The FDA’s Center for Drug Evaluation and Research has recommended withdrawing the approval of Makena for the prevention of recurrent preterm birth after a trial faile...
Topics & Concepts
Drug approvalMedicineClinical researchDrugClinical trialResearch centerFamily medicinePharmacologyInternal medicinePathologyPreterm Birth and ChorioamnionitisPregnancy and Medication ImpactAssisted Reproductive Technology and Twin Pregnancy