March 27, 2014. Given the lack of credible evidence that this injected drug is more effective than placebo, we urge you to advise the FDA to NOT approve it at this time, and to require better research as well as subgroup analyses on African Americans and Latinos.
Read More »On Medical Treatments & Products
NCHR Testimony to FDA Advisory Committee on Visian Toric Implantable Collamer Lens
March 14, 2014. Myopia and astigmatism are extremely common and we approached today’s meeting with hope that the evidence would be solid so that people could benefit from this device. I’m sure you did too. However, we have 2 substantial concerns.
Read More »Conference – Evidence for New Medical Products: Implications for Patients and Health Policy
June 13, 2014. Better implementation of evidence-based medicine can improve the quality and cost-effectiveness of health care in the U.S. This can be challenging in evaluating newly approved drugs and medical devices.
Read More »NCHR Testimony to FDA Advisory Committee on Inspire Upper Airway Stimulator
February 20, 2014. We believe that the device under review today may represent a novel way to improve the lives of patients who are not effectively treated by CPAP. However, we have 2 concerns.
Read More »NCHR Testimony to FDA Advisory Committee on Iontophoresis Devices
February 21, 2014. Class III devices are defined by “potential unreasonable risk of illness or injury”. Based on that definition and the information that was provided to the committee and the public for this meeting, we are convinced, as FDA was for 2 decades, that iontophoresis devices are Class III devices that should be reviewed under the more rigorous PMA process.
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