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Condom HPV labeling

This article was originally published in The Gray Sheet

Executive Summary

Reps. Tom Davis (R-Va.) and Mark Souder (R-Ind.) are pressing FDA to fulfill a legislative mandate directing the agency to review condom labeling to ensure information on the devices' ability to prevent human papillomavirus (HPV) is "medically accurate." HPV recently was added to federal lists of known cancer-causing agents, because certain strains are linked to cervical cancer. Last year, FDA pledged to address HPV and condom labeling by year-end as part of a guidance (1"The Gray Sheet" March 15, 2004, p. 19). The document has yet to be published, Souder and Davis note in a Feb. 11 letter. The reps request that FDA provide within 30 days "a date certain as to when the [agency] will finally be in compliance with Public Law 106-554" and "an explanation for the continued delay by FDA in complying with this four-year-old law." The letter also complains that CDC has been slow to satisfy requirements mandated by the law...
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