The FDA is taking on female sexual dysfunction. Regulatory Focus reports that the regulator will be asking patients questions about the collection of conditions known by the shorthand FSD during a two-day hearing in October.
The meeting is being convened as part of the FDA’s Patient-Focused Drug Development process, which is intended to be a way for the FDA to take into consideration the risks patients say they are willing to take on, as opposed to considering only risk/benefit tradeoffs with which the regulator is comfortable.
A coalition of healthcare groups has been urging the FDA to put women’s sexual health concerns on par with those of men, and kicked off an awareness campaign in June to spur action.
RF says that while FDA has yet to share the questions it expects to ask, the hearing will take place on October 27 and October 28.
