Advisory Panel Members On Unanimous Vote Recommending US FDA Approve OTC Birth Control

NDAC and ORUDAC members acknowledged the FDA’s concerns about some data provided by Opill sponsor HRA Pharma to support its OTC switch application. However, a greater share noted the “historic nature” of the proposal and the broad support expressed in the meeting’s public comment portion.

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Members of a US Food and Drug Administration advisory panel, to a person, concluded that the potential benefits of OTC sales of a daily oral contraceptive outweigh the risks.

Several agreed with FDA concerns about some data the sponsor of the application for the OTC switch provided, but a larger number noted the historic nature of HRA Pharma’s proposal...

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