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GUIDANCE DOCUMENT

Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment Guidance for Industry October 2016

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2016-D-2817
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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 This draft guidance is intended to serve as a focus for continued discussions among the Division of Bone, Reproductive, and Urologic Products, pharmaceutical companies, the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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-2817.

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