NCHR Testimony to FDA in Preparation for the International Cooperation on Cosmetics Regulation Meeting

June 15, 2016. We are concerned about the presence of endocrine disrupting chemical in cosmetics, and their effect on consumers’ health. This issue is not new for the International Cooperation on Cosmetics Regulation (ICCR). It was discussed in 2012 and 2013. It appears that the ICCR asked the cosmetics industry for additional information, but it is unclear whether that information was provided and discussed since 2013.

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Letter to WHO Urging the Postponement or Movement of Brazil Olympics due to Concerns over Zika

May 27, 2016. We are writing to express our concern about the upcoming Olympic and Paralympic Games in Rio de Janeiro. WHO’s declaration of Zika as a “Public Health Emergency of International Concern,” coupled with new scientific findings that underscore the seriousness of that problem, call for the Rio 2016 Games to be postponed and/or moved to another location—but not cancelled—in the name of public health.

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Blood Establishment Computer Software Devices Need Rigorous Safety & Effectiveness Reviews

May 31, 2016. The National Center for Health Research (NCHR) opposes the proposed rule for Blood Establishment Computer Software (BECS) and Accessories, which would classify these devices as class II (special controls). Since there have been injuries and even a death associated with these devices, we strongly recommend they be reviewed through the more rigorous PMA (class III) approval process. PMA applications would provide physicians, researchers, and patients detailed information about the studies and tests submitted to approve the devices—information which is lacking on BECS devices that are currently cleared by the 510(k) process.

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