JAMA Internal Medicine, September 29, 2014. The US Food and Drug Administration (FDA) approves about 400 implanted medical devices each year through an abbreviated process called the 510(k) process, which only rarely requires clinical trials (studies of patients).
Read More »Our Medical Journal Articles
Lack of Diversity in Cancer Drug Clinical Trials May Exacerbate Racial Disparities in Mortality Rates.
Cancer Epidemiology, July 22, 2014. Our brief commentary in Cancer Epidemiology in July 2014 points out that a lack of racial and ethnic diversity in clinical trials submitted to the FDA may exacerbate the growing racial disparity in breast cancer survival, as well as other racial disparities in survival.
Read More »NCHR Comment on Silicone Wristbands as Personal Passive Samplers
Environmental Science and Technology, July 10, 2014. Silicone bracelets may, as “chemical exposure monitors,” act as personal data-gathering devices to document an individual’s chemical exposures.
Read More »Regulatory Reticence and Medical Devices
The Milbank Quarterly, March 6, 2014. Our analysis of the recent history of device regulation in the United States, however, leads to a less optimistic conclusion: that these changes in regulatory policy fail to adequately address the central shortcoming in the regulation of medical devices in the United States and Europe.
Read More »Comment on ‘Statement on Combined Hormonal Contraceptives Containing Third- or Fourth-Generation Progestogens or Cyproterone Acetate, and the Associated Risk of Thromboembolism’
Journal of Family Planning and Reproductive Health Care, July 8, 2013. Despite the increased interest in evidence-based medicine, many medical guidelines and statements of medical professionals are based primarily on opinion rather than scientific facts. The ‘Statement on combined hormonal contraceptives containing third- or fourth-generation progestogens or cyproterone acetate, and the associated risk of thromboembolism’ raises such concerns.
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