Ansell on condom labels
This article was originally published in The Tan Sheet
Executive Summary
FDA's proposed warnings for condoms employing the spermicide nonoxynol-9 are "alarmist and unwarranted" because "there are no studies linking N-9 condoms to vaginal irritation and increased transmission of HIV," Ansell Healthcare Products states in Feb. 10 comments to the agency. N-9 studies that have shown an increased transmission of HIV "involved different vehicles (gels and suppositories) as well as dramatically higher doses (50 mg-150 mg vs. < 32 mg)" than is typical of N-9 condoms, the LifeStyles manufacturer adds. The agency proposed label warnings in November which would state that N-9 can increase the risk of getting HIV/AIDS from an infected partner if used regularly (1"The Tan Sheet" Nov. 21, 2005, p. 13). Ansell also objects to including in labeling a table comparing various contraceptive methods because it contains "Typical Use" rates, which are "not based on scientifically valid data."...
You may also be interested in...
Latex Condom Labels Would Bear N-9, STD Warnings Under FDA Proposal
Labeling for condoms that employ nonoxynol-9 should be amended to state that spermicidal lubricants may increase HIV transmission, FDA says in a proposed rule published in the Federal Register Nov. 14
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.
EU Parliament Stricter Than Council On Medicines And Medical Devices Packaging
The EU Parliament's Environment, Public Health and Food Safety committee takes a compromise position with regards to the Packaging and Packaging Waste Directive. Medicines and medical devices should be exempt, but only until 2035, at which point the European Commission should check whether the development of materials and the recycling process have progressed, and may adjust this exemption accordingly.