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 »We’re Speaking Out on Health Issues
NCHR scientists and health policy experts provide written and oral statements on a wide range of topics.
Here are many of the ways we have been Speaking Out on Health Policy Issues for the last few years. Whether the topic is legislation intended to cure diseases, proposed bans on BPA or other chemicals that disrupt your hormones, the importance of including women, people of color, and patients over 65 in clinical trials, or many other topics, you’ll gain a better understanding of our evidence-based analyses by reading these letters, statements, and testimony.
Here are the ways we have been Speaking out on Medical Treatments and Products, such as prescription drugs and medical devices that the FDA is considering approving, or is considering taking off the market because of serious risks. Whether the topic is Chantix, Addyi, Yaz, Essure, or medical products you’ve never heard of, you can find out more about what is known and not known about the safety and effectiveness of a wide range of products by looking through this section of our website.
NCHR Comments on Modernizing FDA’s 510(k) Program
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 »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.
Read More »NCHR Report: The Health Risks of MRIs with Gadolinium-Based Contrast Agents
Gadolinium-based contrast agents can improve the diagnostic accuracy of MRIs, however gadolinium can stay in the body for months or years. There are many unanswered questions about who develops health problems related to gadolinium, how to determine if symptoms are due to gadolinium, and how to prevent or treat gadolinium-related conditions.
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