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.

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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.

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