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FDA issues draft guidance for condom labels.(News)
New guidance from the Food and Drug Administration proposes that latex condom labels inform users that condoms greatly reduce, but do not eliminate, the risk of pregnancy and the risk of contracting or spreading HIV or other sexually transmitted diseases.
The draft guidance from FDA, which is nonbinding, also recommends that the package insert for latex condoms say that condoms cannot protect against STDs such as human papilloma virus and genital herpes when they spread through contact with infected skin outside the area covered by the condom and states that nonoxynol-9 could irritate the vagina and rectum and therefore may increase the risk of acquiring HIV/AIDS from an infected partner.
The proposed guidance is the result of a 5-year-old law that directs the FDA to ensure that condom labels are medically accurate, specifically in regard to their overall effectiveness in preventing ...
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...Administration proposes that latex condom labels inform users that condoms greatly...sexually transmitted diseases. The draft guidance from FDA, which is nonbinding...directs the FDA to ensure that condom labels are medically accurate, specifically...
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FDA made available a draft guidance on implementation of the Reportable Food Registry, entitled "Draft Guidance for Industry: Questions and Answers...Administration Amendments Act of 2007." The draft guidance, together with a CENTER FOR FOOD...
- OIG releases draft guidance for ambulance providers.
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OIG releases draft guidance for ambulance providers The Health...Washington, DC, the new element in the draft guidance is its attempt to identify specific...identified several points where the draft guidance differs from recent guidance published...
Source: HighBeam Research, FDA issues draft guidance for condom labels.(News)