August 6, 2019. There are reasons why a drug or device may be less safe or less effective for women, children, older patients, or certain ethnic or racial subgroups. These differences in results for under-represented subgroups may not be minor or trivial. This is why sufficient inclusion of under-represented groups is so important.
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NCHR Comments on FDA’s Guidance on Post-Approval Pregnancy Safety Studies
June 28, 2019. Currently, 9 in 10 women take at least one medication during their pregnancy, and 7 in 10 women take at least one prescription medication during their pregnancy. It is therefore vital to develop safety profiles of drugs used during any stage of pregnancy. Those studies must be subject to rigorous methodology and surveillance.
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 »NCHR Comments on Modernizing FDA’s 510(k) Program
May 22, 2019. The 510(k) pathway system is flawed, and should be replaced with pathways that require controlled clinical trials for all implanted devices and many other devices as well. Meanwhile, safety can be improved with our recommendations.
Read More »NCHR Comments on CPSC Agenda and Priorities for FY2020/2021
May 1, 2019. CPSC has a key role to play in protecting children and adults from harmful products used in their daily life. CPSC should consider artificial turf and playground surfaces, organohalogen flame retardants, and sport and recreational helmets as priorities for FY2020 and 2021.
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