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OTC vaginal spermicide dose range establishment in clinical trials urged by FDA.

This article was originally published in The Tan Sheet

Executive Summary

OTC VAGINAL SPERMICIDE OPTIMAL DOSE RANGE ESTABLISHMENT through future clinical studies is urged by FDA in a Nov. 7 feedback letter to Nonprescription Drug Manufacturers Association Senior VP & Director of Science & Technology William Soller, PhD. Due to the lack of definitive dose-response data on marketed nonoxynol-9 (N-9) spermicide products, the agency considers "establishing an optimal dosing range of major importance." The letter addresses what FDA perceives to be "relevant in determining the safety and efficacy of OTC vaginal spermicides."
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