Washington Post, June 3, 2020. There are lots of challenges facing major league baseball’s efforts to avoid the coronavirus. We explain that one of the biggest challenges are the hot spot states where baseball teams are supposed to play.
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NCHR Comments on FDA’s Notice on the Modified Risk Tobacco Product Application for Copenhagen Snuff Fine Cut
January 21, 2020. We strongly oppose the approval of the modified risk application for Copenhagen Snuff Fine Cut with the claim “IF YOU SMOKE, CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer.” This claim may encourage non-smokers to begin using tobacco. Using smokeless tobacco increases the risk of serious health issues.
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Read More »NCHR Comment on FDA’s 510(k) Third Party Review Program Draft Guidance
December 13, 2018. The third party review program clearly moves in the opposite direction, reducing patient safety, rather than protecting patients from potentially harmful devices. We strongly oppose it for that reason.
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