September 10, 2019. As members of the Patient, Consumer, and Public Health Coalition, we are writing to express our strong support for the reauthorization of the Patient-Centered Outcomes Research Institute (PCORI).
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NCHR Letter to Congress Supporting Reauthorization of Patient-Centered Outcomes Research Institute (PCORI)
September 12, 2019. If the United States is to regain the stature of offering a top-notch healthcare system that is the model for other countries and make the most of our considerable investment in personalized and precision medicine, PCORI must be sustained.
Read More »NCHR Comment on FDA’s Draft Guidance Regarding Use of an Alternate Name for Potassium Chloride in Food Labeling
September 17, 2019. NCHR supports the name “potassium salt” in the ingredient statement as an alternative to the name “potassium chloride.” The name “potassium salt” would be more understandable to consumers and manufacturers, thereby facilitating sodium reductions in processed foods and improving public health.
Read More »NCHR Comments on FDA’s Draft Guidance on Enhancing the Diversity of Clinical Trial Populations
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.
Read More »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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