February 26, 2016. There are a number of devices currently on the market that pose safety risks to the public because they were inappropriately designated Class I. The upclassification of the surgical mesh instrumentation from class I to class II as well as the new classification of centrifuge apheresis devices as class II are both moves towards increasing patient safety. The special controls suggested by the FDA should be carefully evaluated to determine if they are adequate to protect patients from undue harm.
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NCHR Testimony at FDA on TOPAS Treatment for Fecal Incontinence
February 25, 2016. The lack of a comparison group or data for substantial groups of women most likely to suffer from fecal incontinence makes it impossible to determine if this device would benefit them. A control group is needed to determine if the device is effective for anyone, and if it is, it should be approved only for the types of women studied, not for the types of women who were intentionally excluded.
We encourage you to recommend that these studies be conducted before a decision is made about whether or not to approve this device.
NCHR Testimony at 2016 FDA Meeting on Leadless Cardiac Pacemakers
February 18, 2016. Leadless pacemakers have the potential to improve the care of patients with various cardiac rhythm disorders. However, this will require an understanding of how acute adverse events compare and contrast with those of traditional pacemakers. I encourage you to urge the FDA to require comprehensive data regarding the intermediate and long-term safety and effectiveness of leadless pacemakers. Post approval studies should clearly assess these diverse factors. They should provide context regarding the entire spectrum of safety and effectiveness in a way that enables physicians to make sound decisions, and that allows patients to fully and clearly understand the risks and benefits of this new technology.
Read More »NCHR Testimony at FDA on Vortioxetine Treatment of Cognitive Dysfunction in Major Depressive Disorder
February 3, 2016. NCHR urges FDA to conclude that there is insufficient data to claim that vortioxetine is effective in providing a meaningful improvement in cognitive dysfunction associated with MDD.
Read More »NCHR Testimony on Probuphine at FDA Advisory Committee Meeting
January 12, 2016. We need safe and effective treatment options for opioid addiction. Unfortunately, the risk-benefit profile of probuphine does not support its approval for the population studied.
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