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 the Food and Drug Administration’s (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. This draft guidance is intended to serve as a focus for continued discussions among the Division of Bone, Reproductive, and Urologic Products, pharmaceutical companies, the academic community, and the public.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.