Women’s Low Sexual Interest: NCHR Comment on FDA Guidance

December 23, 2016. There is a need to find treatments for low sexual interest, desire, and/or arousal in women, as those conditions affect women’s quality of life. However, the scientific standards should be solid, and consistent with long-term use, if that is the intent. If a sponsor does not want to conduct a large enough study to carefully evaluate safety and efficacy for all the known subgroups, the FDA should approve the drug only for those subpopulations that have been found to have benefits that outweigh the risks.

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NCHR Testimony at 2016 FDA Workshop on Role of Hospitals in Modernizing Evidence Generation for Device Evaluation

December 5, 2016. Hospitals are expected to play a key role in evidence generation and adverse event reporting for the National Evaluation System for Health Technology. While the collection and analysis of real-world data will be important for post-market surveillance of medical devices, the quality of information being collected and used for decision-making must be focused on making patient safety a priority.

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NCHR’s View of the 21st Century Cures Act

December 5, 2016. Passing a complicated health bill in the rush of a lame-duck session is always problematic. Passing a 996-page bill that was negotiated behind closed doors and includes provisions that were never voted on before represents the kind of legislative sausage that the world’s greatest deliberative body should reject.

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National Center for Health Research’s Public Comment on USPSTF Draft Recommendation Statement and Draft Evidence Review on Obesity in Children and Adolescents: Screening

November 28, 2016. Childhood obesity is a serious problem and intensive behavioral interventions to promote improvements in weight status have benefits for some children and adolescent populations. However, we are concerned that due to limitations in the quality of the research supporting the recommendations, they may not be appropriate for all children and adolescents.

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Letter to Senators on the Innovation for Healthier Americans Bills

November 8, 2016. We respectfully urge you to not advance the Senate’s Innovation for Healthier Americans bills or the House’s 21st Century Cures Act during the lame duck session of Congress. While the House version of the legislation provides additional funding for the National Institutes of Health (NIH), both the House and the Senate versions contain more controversial measures which would lower safety and approval standards for drugs and medical devices at the Food and Drug Administration (FDA).

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