May 31, 2019. The safety and effectiveness of new devices needs to be established before they are approved. Approval of products without this evidence puts patients at risk for unnecessary harm. Adequate and well-controlled clinical trials are the best way to establish that the benefits outweigh the risks for patients needing collagen-based hemostatic devices.
Read More »On Medical Treatments & Products
NCHR Comments on FDA’s Reclassification of Surgical Staplers
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 »NCHR Testimony at FDA at the Onolcogy Drugs Advisory Committee Meeting on Quizartinib
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 »NCHR Comments on Responsible Innovation in Dietary Supplements
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.
NCHR Testimony on Mannitol Inhalation Powder for Cystic Fibrosis
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.
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