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.

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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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