OTC vaginal spermicide feedback meeting
This article was originally published in The Tan Sheet
Executive Summary
"Will be useful to discuss such topics as dose-ranging studies, study protocols, and in vivo and in vitro testing needed to demonstrate comparative safety and efficacy," FDA tells NDMA in a June 3 letter. The agency urged industry to establish the optimal dose range for nonoxynol-9 spermicide products in a Nov. 7 feedback letter ("The Tan Sheet" Dec. 1, 1997, p. 13). "Our recommendations for dose-ranging studies would allow manufacturers whose OTC dose/dosage form was not part of the NICHD study, to conduct comparative clinical trials using the optimal dosing range and, perhaps, to bridge the results to other relevant clinical data," FDA explains. The agency adds, however, the final marketing status of an OTC vaginal spermicide depends on its meeting FDA standards whether through the monograph or NDA process...