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...