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

 
• By Malcolm Spicer

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.

• Source: Shutterstock

Concerns about a portion of the study supporting a proposal for an Rx-to-OTC switch of 0.075-mg norgestrel as a daily oral contraceptive in the US have prompted the Food and Drug Administration to ask an advisory panel to recommend a better study.

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More from Policy & Regulation

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