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‘Over-Reporting’ An ‘Inherent Risk’ In Self-Report Study – Oral Contraceptive OTC Switch Sponsor

HRA Says Results Supporting Safe OTC Not Affected While Cause ‘Incompletely Understood'

 
• By Malcolm Spicer

HRA says its research in support of its sNDA for its 0.75-mg norgestrel tablet branded Opill shows accurate OTC self-selection and safe use of the progestin-only drug by females of reproductive age.

• Source: Shutterstock

The volume of HRA Pharma’s research information for its proposal for the first OTC switch of a daily oral contraceptive in the US will be weighed against Food and Drug Administration concerns including actual use study results showing some participants reported using more doses than they received.

In its briefing material for the FDA’s Nonprescription Drug and the Obstetrics, Reproductive and Urologic Drugs advisory committees’ meeting on 9-10 May which will be conducted online, HRA states...

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