January 9, 2020. Officials in communities all over the country have been misled by artificial turf salespeople. They were erroneously told that these products are safe. But on the contrary, there is clear scientific evidence that these materials are potentially harmful. The only question is how harmful and how much exposure is likely to be harmful? We should not be willing to take such a risk. Our children deserve better.
Read More »On Health Policy
NCHR’s Comments on NIH Draft Policy on Data Sharing
January 3, 2020. Our Center has supported data sharing, and particularly for data funded by federal agencies or submitted to federal agencies as part of application materials to the FDA and other federal agencies.
Read More »NCHR’s Comments on FDA’s Best Practices in Drug and Biological Product Postmarket Safety Surveillance
January 6, 2020. The draft document describes how FDA staff evaluates postmarket safety surveillance but lacks some essential information about FAERS, post-marketing studies, the Sentinel Initiative, and safety signal resolution.
Read More »NCHR Comments FDA’s Draft Guidance on Clinical Decision Support Software
December 23, 2019.We appreciate FDA clarifying plans for regulating Clinical Decision Support (CDS) software; however, we have concerns regarding the draft guidance.
Read More »NCHR Comments on FDA’s Draft Guidance on Post-Market Studies and Clinical Trials
December 20, 2019. Post-market clinical trials and other studies can help inform FDA and the public about the risks and benefits of medical products. However, when they are relied upon to answer questions better addressed prior to approval, or if less effective studies or trials are used, or if studies are delayed and inadequate, they do not provide the intended data that is needed by FDA, patients, and healthcare providers. This adds to the already high cost of medical care.
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