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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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Regulatory Affairs Professionals Society Meeting In Brief

PMA supplement guidance, finally?: "I'm going to go out on a limb and say it will be out by the end of the calendar year," Office of Device Evaluation Director Donna-Bea Tillman said Oct. 16 at the Regulatory Affairs Professionals Society (RAPS) annual meeting in Baltimore in reference to a highly-anticipated PMA product modification guidance. The guidance, which is expected to define specific PMA supplement types and lay out criteria for when to proceed with each, will replace a 1998 guidance on the topic that FDA removed from its website in 2005 (1"The Gray Sheet" May 30, 2005, p. 3). CDRH PMA Section Director Thinh Nguyen had told an audience at the 2005 RAPS meeting to expect the guidance in early 2006. "It's been a very difficult guidance. A lot of different people have had to see it and weigh in on it," Tillman said. "We know that the industry wants that guidance"...

Regulatory Affairs Professionals Society Meeting In Brief

PMA supplement guidance, finally?: "I'm going to go out on a limb and say it will be out by the end of the calendar year," Office of Device Evaluation Director Donna-Bea Tillman said Oct. 16 at the Regulatory Affairs Professionals Society (RAPS) annual meeting in Baltimore in reference to a highly-anticipated PMA product modification guidance. The guidance, which is expected to define specific PMA supplement types and lay out criteria for when to proceed with each, will replace a 1998 guidance on the topic that FDA removed from its website in 2005 (1"The Gray Sheet" May 30, 2005, p. 3). CDRH PMA Section Director Thinh Nguyen had told an audience at the 2005 RAPS meeting to expect the guidance in early 2006. "It's been a very difficult guidance. A lot of different people have had to see it and weigh in on it," Tillman said. "We know that the industry wants that guidance"...

Condom use and HPV

Results published in the June 22 New England Journal of Medicine suggest that condoms effectively reduce the risk of human papillomavirus (HPV) transmission. Investigators Rachel Winer, PhD, University of Washington, et al., report that women whose partners used condoms for all instances of intercourse over an eight-month period were 70% less likely to acquire a new infection than women whose partners used condoms less than 5% of the time. None of the women who reported always using condoms developed HPV lesions during the study period. Data also suggests that condom use aids in the prevention of high-grade cervical neoplasia and invasive cervical cancer, but larger data sets are needed to confirm these trends, the authors say. The investigation sheds light on questions raised by Congress about the accuracy of condom labeling for HPV and other sexually transmitted diseases (1"The Gray Sheet" Nov. 14, 2005, p. 17)...

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