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Beyond Gender Bias – Lessons from the
Female Libido Drug’s Path To Approval

March 25, 2014
Jennifer Mallory

Reprinted with permission of Pharmaceutical Compliance Monitor

Female libido drug candidate flibanserin has rekindled a debate about gender bias in the Food and Drug Administration’s drug approval process. The debate centers on that agency’s approval of 24 drugs to treat male sexual dysfunction and its failure to approve even one drug to treat female sexual dysfunction. While commentators and politicians debate alleged gender bias at a federal agency headed by a woman, the flibanserin story provides important lessons for pharmaceutical and biotech companies that run into obstacles along the path toward approval.

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