February 24, 2015. It is clear that patients suffering from Keratoconus or Corneal ectasia need treatment options. The risk-benefit analysis may support approval of corneal cross-linking for those patients, however we are very concerned about the data presented here showing limited efficacy. We are also extremely concerned about off-label use of this risky technology. The incidence of adverse events from the cross-linking procedure is very high, so this procedure should NOT be used except for those diseases/conditions.
Read More »On Medical Treatments & Products
Letter to FDA Commissioner Hamburg on New Antibiotic Product (CAZ-AVI)
December 19, 2014. We are writing to express our strong concerns about the approval standards considered and the conflicts of interest apparent at the December 5, 2014 FDA meeting of the Anti-Infective Drugs Advisory Committee (AIDAC) regarding a new combination antibiotic product, ceftazidime-avibactam (CAZ-AVI).
Read More »Comments on Reclassification of Iontophoresis Devices Intended for Any Other Purposes
December 22, 2015. As members of the Patient, Consumer, and Public Health Coalition, we strongly oppose the down classification of iontophoresis devices intended for any other purposes from Class III to Class II (special controls).
Read More »Comments on Reclassifying External Pacemaker Pulse Generator Devices and Pacing System Analyzers
December 15, 2014. We strongly oppose the down-classification of External Pacemaker Pulse Generator (EPPG) devices and Pacing System Analyzers (PSAs) from Class III to Class II. The Cardiovascular Devices Panel stated on March 9, 1979 that these devices should be classified into Class III because the device “provided temporary life-support and that certain kinds of failures could cause this device to emit inappropriate electrical signals, which could cause cardiac irregularities and death.”
Read More »NCHR Testimony at FDA Advisory Committee on Anti-Infective Drugs
December 5, 2014. We are all concerned about the growing problem of antibiotic resistance. We want to ensure effective treatment options for those with serious infections. However, ineffective antibiotics actually worsen our situation by increasing antibiotic resistance.
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