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OTC vaginal contraceptives TFM vacated; FDA asks for NDAs/ANDAs.

This article was originally published in The Tan Sheet

Executive Summary

OTC VAGINAL CONTRACEPTIVE CLINICAL TRIALS UNDER "ACTUAL USE" CONDITIONS are required under FDA's tentative final monograph covering over-the-counter vaginal contraceptives. Published in the Feb. 3 Federal Register, the TFM would require manufacturers of OTC vaginal contraceptives to obtain approved NDAs or ANDAs for their products and test each product "in appropriate clinical trials under actual conditions of use."
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