September 10, 2019: In response to FDA’s request for public comments, we stated that the agency should require better testing of hormonal birth control pills and patches. Current studies don’t include enough women with higher BMIs or track blood clot risks properly. Our comments push for stronger safety standards that test hormonal contraceptives on women of all weights, especially since some birth control methods may be less effective or more dangerous for larger women.
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FDA approves new female Viagra despite skepticism
Washington Post: June 21 2019. FDA approves Vyleesi, a new drug for women with low sexual desire, but health experts worry about its safety and effectiveness compared to placebo. Diana Zuckerman points out there is “skimpy peer-reviewed data and a complete lack of long-term safety information” for the self-administered injection.
Read More »More Than Half Of Surgical Stapler Malfunctions Went To Hidden FDA Database
KHN: May 30, 2019. Thousands of patients were harmed and dozens killed by malfunctioning surgical staplers. Most of that information was hidden in an FDA database that was not publicly available, which NCHR criticizes as covering up information patients and physicians need to make informed decisions.
Read More »NCHR Comment on Regulating Artificial Intelligence/Machine Learning-Based Software
June 3, 2019. Artificial Intelligence/Machine Learning (AI/ML)-based software device that incorporates special computer techniques (algorithms) capable of detecting relevant medical patterns from large amounts of data. These very sophisticated pattern recognition capabilities (AI/ML) have broad potential healthcare applications, including making recommendations to healthcare providers and patients about the diagnosis, prognosis, treatment, or prevention of disease.1 The complexity, scalability, and broad scope of these new technologies thus raise important issues regarding their safety and effectiveness as it pertains to patients’ health.
Read More »NCRH Testimony on Reclassification of Collagen-Based Hemostatic Devices
May 31, 2019. The safety and effectiveness of new devices needs to be established before they are approved. Approval of products without this evidence puts patients at risk for unnecessary harm. Adequate and well-controlled clinical trials are the best way to establish that the benefits outweigh the risks for patients needing collagen-based hemostatic devices.
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