Regulatory and drug development issues related to female sexual dysfunction.
Following the approval of sildenalfil for the treatment of erectile dysfunction, an increased awareness of and interest in female sexual dysfunction developed on the part of the academic and research communities as well as the pharmaceutical industry. This article will focus on regulatory issues related to the development of drug products to treat female sexual dysfunction and will describe a recently published drug development guidance document for this indication.
Allen
Susan S
SS
Division of Reproductive and Urologic Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Washington, D.C., USA. allensu@cder.fda.gov
D002986:Clinical Trials as Topic; D004358:Drug Therapy / Q000379:methods*; D004335:Drug and Narcotic Control; D005260:Female; D006801:Humans; D020018:Sexual Dysfunctions, Psychological / Q000188:drug therapy*; D011795:Surveys and Questionnaires; D014481:United States; D014486:United States Food and Drug Administration