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Oral Contraceptive Switch Advocates Reject User Age As Approval Factor

 
• By Malcolm Spicer

FDA could soon receive an NDA from non-profit research group Ibis Reproductive Health and HRA Pharma, for an oral contraceptive switch in the US.

An application to allow OTC access to an oral contraceptive soon could reach FDA. Proponents already are pushing for its review to be based solely on a safety and efficacy analysis that leaves customer age out of the equation.

Groups such as the Oral Contraceptives Over-the-Counter Working Group want to make sure that age, the controversial element in FDA’s decision on nonprescription sales of emergency contraceptives, does not resurface, even though a

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