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

 
• By Malcolm Spicer

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.

• Source: Shutterstock

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...

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