Vaginal contraceptive monograph approach would still need clinical data -- FDA.
This article was originally published in The Tan Sheet
VAGINAL CONTRACEPTIVE OTC MONOGRAPH BASED ON FORMULATION STANDARDS and in vitro studies may be a viable approach for FDA regulation once the agency is provided with clinical data demonstrating actual effectiveness of the spermicides in preventing pregnancy, FDA representatives told the Nonprescription Drug Manufacturers Association at a Sept. 24 OTC "feedback" meeting in Rockville, MD.
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