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 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.

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