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 »On Medical Treatments & Products
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.
Read More »NCHR Testimony on the Platelet Inhibitor Drug, Cangrelor
February 12, 2014. Testimony of Laurén Doamekpor, Senior Fellow with NCHR, on Cangrelor to the FDA Cardiovascular and Renal Drugs Advisory Committee.
Read More »NCHR Testimony to the FDA Advisory Committee Regarding Dapagliflozin (Farxiga)
December 12, 2013. NCHR expresses concerns about this drug that there are just too many unanswered questions – and those unanswered questions are frightening ones.
Read More »NCHR Testimony on Telavancin (VIBATIV) to FDA
November 29, 2012. Dr. Yttri testifies to the FDA that there is not sufficient evidence to support telavancin as a safe and effective treatment for nosocomial pneumonia. The data raise questions about a high mortality rate associated with telavancin.
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