Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment; Draft Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment." The purpose of this guidance is to assist sponsors in developing drugs for the treatment of low sexual interest, desire, and/ or arousal in women. Specifically, this guidance addresses FDA's current thinking regarding the overall clinical development program, with a focus on phase 3 trial designs, to support an indication for the treatment of these conditions.