June 28, 2019: NCHR public comment urges FDA to require safety studies of drugs taken during or after pregnancy that include women of all races, ethnicities and access to insurance. FDA should require better tracking of medication risks, and ensuring that research represents all races, ethnicities, and insurance types (including uninsured women and those on Medicaid). With 9 out of 10 pregnant women taking medications, we need better safety data to protect both mothers and babies.
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NCHR Testimony on Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents
June 20, 2019. We agree with the FDA and the Panel that the increased risk for death for patients treated with paclitaxel-coated balloons or –eluting stents, as shown in the meta-analysis of randomized pivotal trials, is very concerning. Any potential increase risk for death is important for health care professionals and patients to know about, so that they can make appropriate decisions about whether to use a product.
Read More »NCHR Testimony on Pretomanid for Tuberculosis
June 7, 2019. While new treatments are needed, it is impossible to accurately determine the risks or benefits of a new TB treatment without a randomized trial or a matched control group within the same trial. As clinicians and patients, you deserve to know the benefits and risks before deciding which treatments to use. This information is needed before approval, not years later.
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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