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 »On Medical Treatments & Products
Comments on Effective Date for Premarket Approval for Three Class III Devices; Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose
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 the three preamendment devices referred to in this docket because they pose substantial risks and the benefits of these devices are “unknown” and there is “limited scientific evidence” regarding their effectiveness.
Read More »NCHR Comments on Proposed Order Regarding Transilluminator for Breast Evaluation
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 »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.
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