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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.

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Over The Counter: Evolving The UK Consumer Health Industry, With PAGB’s Michelle Riddalls

 
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