First OTC Oral Contraceptive Has Advisory Panel’s Unanimous Support Despite FDA’s Data Concerns
Executive Summary
FDA officials again made clear concerns about “improbable dosing” data in HRA’s sNDA for 0.075-mg norgestrel tablet branded Opill before advisory panel voted at close of a two-day meeting conducted 60 years after first Rx oral contraceptive approved in US.
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When History Has Its Eyes On You: Opill Vote Puts US FDA In Tough Spot
A unanimous US FDA advisory committee vote in favor of a landmark decision to make oral contraceptives available without a prescription should be history in the making. But the desire to make history – rather than address FDA’s significant concerns with the actual application for Perrigo’s Opill – seems to have carried the day.
When History Has Its Eyes On You: Opill Vote Puts US FDA In Tough Spot
A unanimous US FDA advisory committee vote in favor of a landmark decision to make oral contraceptives available without a prescription should be history in the making. But the desire to make history – rather than address FDA’s significant concerns with the actual application for Perrigo’s Opill – seems to have carried the day.
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.