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End Of The Line For Makena?

Executive Summary

Pink Sheet infographic shows the many regulatory challenges and sponsors that the preterm birth prevention drug has endured leading up to the US FDA's proposal for market withdrawal.

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Accelerated Approval: US FDA Request For Makena’s Withdrawal Goes Beyond Failed Confirmatory Trial

Preterm birth prevention drug should come off the market to ensure the accelerated approval pathway does not operate as a lower approval standard, agency says; proposed withdrawal comes almost a year after an advisory committee split on the question of whether Makena should stay on the market in light of delayed, and ultimately unsuccessful, confirmatory study.

2020 In Review: US FDA New Drug Office’s COVID-19 Response Aided By Reorganization

Office of New Drugs Director Peter Stein tells the Pink Sheet that last phase of massive reorg was complicated by pandemic restrictions that forced review staff to work remotely, but the structural overhaul resulted in smaller, more nimble review groups and the breaking down of silos that ultimately helped the agency’s response to the public health crisis.

Postmarketing Safety Gets Closer Focus In Latest US FDA Drugs Center Reorganization

Division of Mitigation Assessment and Medication Error Surveillance will be established within the Office of Surveillance and Epidemiology, a change aimed at strengthening postmarketing oversight of opioids and other drugs; new Office of Safety and Clinical Evaluation will be created in Office of Generic Drugs, where Orange Book staff also will get their own division.

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