Draft Guidance on Developing Drugs for Treatment of Low Sexual Desire, Interest or Arousal

["FDA Office of Women's Health" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Draft Guidance on Developing Drugs for Treatment of Low Sexual Desire, Interest or Arousal

FDA Office of Women's Health

www.fda.gov/womens

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Draft Guidance on Developing Drugs for Treatment of Low Sexual Desire, Interest or Arousal 

Today the FDA issued draft guidance titled Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment.  The draft describes FDA’s current thinking on Phase III trial design features for drugs intended to treat low sexual interest, desire, and/or arousal in women and is intended to help foster continued discussions among the FDA, pharmaceutical companies, the academic community and the public about the development of treatments in this area.

The draft guidance is available on the FDA’s website.

The comment period is open for 60 days. Information on submitting comments is available in the Federal Register.  

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Please share this update with your network, members, constituents, and community. 

FDA Office of Women’s Health

10903 New Hampshire Avenue

WO32 - Room 2333

Silver Spring, MD

20993-0002

301-796-9440

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