May 22, 2103. Pedicle screw systems are used to stabilize the spines of patients who need spinal fusions to correct spine injuries, deformations, or degeneration. Dr. Yttri pointed out the lack of clear clinical evidence that pedicle screw systems are beneficial for patients and how the FDA should require clinical testing before approving new devices.
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 to the FDA on Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis
May 8, 2013. The National Research Center for Women & Families and the TMJ Association oppose the reclassification of Temporary Mandibular Condyle prosthesis, a preamendments class III device, into class II. The proposed special controls are not rigorous enough to provide a reasonable assurance of the device’s safety and effectiveness.
Read More »Comments on Proposed Order Regarding Cranial Electrotherapy Stimulator Devices
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 cranial electrotherapy stimulator 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 »Comments on Proposed Order Regarding Sorbent Hemoperfusion Devices
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 sorbent hemoperfusion devices because they pose substantial risks and the benefits of these devices are “unknown” and there is “limited scientific evidence” regarding their effectiveness.[1] We strongly oppose down- classifying the devices for the treatment of poisoning and drug overdose.
Read More »Patient, Consumer, and Public Health Coalition Letter Re: HELP Committee’s Draft Proposal on Pharmaceutical Compounding
May 6, 2013. The Patient, Consumer, and Public Health Coalition expressed concern that the draft does not adequately address the public health threats posed by compounding pharmacies and will not do enough to prevent future health care crises. The Coalition provided comments on how to improve the draft to better protect the American public.
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