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OTC vaginal contraceptive NDAs would each cost $1 mil., NDMA estimates.

This article was originally published in The Tan Sheet

Executive Summary

OTC VAGINAL CONTRACEPTIVE NDAs WOULD COST $1 MIL. per application to develop, conduct, and analyze a clinical study that would simulate "actual conditions of use," NDMA maintained in June 5 comments to FDA. In response to the agency's call for NDAs for OTC vaginal contraceptives under a tentative final monograph published Feb. 3, the Nonprescription Drug Manufacturers Association stated that "the estimated cost for development, conduct and analysis of a clinical study to address FDA's proposal for an in vivo study to support each vaginal spermicide through an NDA range would be in the range of $1 mil."
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