FDA May Ask HRA For Another OTC Birth Control Actual Use Study Due To ‘Improbable Dosing’
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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FDA’s approval of OTC counter oral contraceptive is milestone moment in public health, but not a straightforward regulatory decision.
The US FDA’s approval of an over-the-counter oral contraceptive is a milestone moment in public health, but it certainly isn’t a straightforward regulatory decision.
The US FDA took three high profile applications to an external advisory committee meeting during the week of 8 May – and offered a very skeptical read on the approvability of each. All three won positive votes from the committees, in no small part thanks to the messages delivered during the Open Public Hearings.