From STAT: It “looks like the FDA is using this guidance to keep another company from trying to get a female sexual desire drug approved based on unreliable data collection instruments and weak results,” said Cindy Pearson, executive director of the National Women’s Health Network, who opposed the approval. “Unfortunately, the FDA is locking the barn door after the horse got out. So now, the agency is telling other companies to do some things that Sprout didn’t do.”
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That does sound like a bit much.