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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Condom labeling: FDA proposes new latex condom labeling in a 1draft guidance and Federal Register 2notice posted on the agency's website Nov. 10. In 2000, Congress mandated FDA to reexamine condom labeling for medical accuracy, particularly with regard to the ability to provide protection from transmission of human papillomavirus (HPV). The labeling would indicate that latex condoms provide less protection for sexually transmitted diseases, such as HPV, which can be transmitted by contact with skin outside the area of condom coverage. But it would also note that condoms may provide some benefit in reducing the risk of HPV-related diseases, such as cervical cancer. Senator Tom Coburn (R-Okla.), who put a hold on Lester Crawford's nomination for FDA Commissioner in June because of FDA's delay in issuing the condom labeling guidelines, expressed dissatisfaction with the document. "The agency continues to promote inconclusive assurances that put women unknowingly at risk for cervical cancer, or worse," he said Nov. 10...
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