May 30, 2019. Thousands of adverse events associated with surgical staplers had been hidden from patients and physicians prior to the March 2019 Kaiser Health News expose. Such devices must be better regulated and monitored.Read More »
May 14, 2019. We need new treatments for this deadly disease, but we need to know if a new drug is BETTER than existing treatments. The fact that Quizartinib is quite similar in risks and benefits to chemo, which is not very effective and provides a poor quality of life, is not a good reason to approve this drug.Read More »
May 22, 2019. The 510(k) pathway system is flawed, and should be replaced with pathways that require controlled clinical trials for all implanted devices and many other devices as well. Meanwhile, safety can be improved with our recommendations.Read More »
May 16, 2019. The dietary supplement industry has made substantial progress in
weeding out bad actors since the “wild, wild West”, largely unregulated days of the mid-
1990’s. We support FDA’s recent efforts to crack down on manufacturers who make false or
misleading claims about their dietary supplements.
May 9, 2018. It is uncertain if the benefits outweigh the risks based on the data discussed today. However, there should be sufficient evidence of both safety and efficacy before approval.Read More »