May 6, 2013. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA requiring the premarket approval (PMA) process for Transilluminator for breast evaluation devices because they pose substantial risks and the benefits of these devices are “unknown” and there is “limited scientific evidence” regarding their effectiveness.
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 Testimony at FDA meeting on Juvederm Voluma XC
May 2, 2013. Testimony on Juvederm Voluma XC FDA Advisory Committee on General and Plastic Surgery Devices, Caitlin Kennedy, Senior Fellow.
Read More »NCHR Testimony on Tivozanib for Kidney Cancer
May 2, 2013. Dr. Jennifer Yttri testified at the FDA that more information is needed on the safety and benefits of the drug tivozanib before it should be considered for treatment of advanced kidney cancer.
Read More »Patient, Consumer, and Public Health Coalition Comments to FDA: Don’t Need a New Pathway for Antibiotics for Limited Populations!
January 30, 2013. The FDA considered a new way to approve drugs for use in small patient populations. NRC warn that such a pathway would put patients at risk of harm by giving them poorly studied drugs without knowing if the drugs provide any benefit.
Read More »Comments to the FDA on Premarket Approval for Metal on Metal Hip Replacements
April 18, 2013. NRC strongly supports the FDA’s proposed order to require that metal on metal hips be approved through the premarket approval (PMA) process, which requires more rigorous testing of the devices than the current 510(k) process.
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