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FDA May Ask HRA For Another OTC Birth Control Actual Use Study Due To ‘Improbable Dosing’

Executive Summary

With “improbable dosing in approximately 1/3 of participants” in HRA actual use study, FDA asks advisory committees to recommend design changes if it asks firm for another study. FDA asked HRA to explain discrepancies after it began reviewing the firm’s sNDA submitted in June 2022.

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