Comments on Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina

August 19, 2013. We are writing as members of the Patient, Consumer, and Public Health Coalition to express our concerns about the proposed down-classification from Class III to Class II of External Counter-Pulsating (ECP) devices for treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization.  We strongly support the proposed PMA for other indications for the same ECP devices.

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Comments to FDA on New Approaches to Antibacterial Drug Development

July 30, 2013. As members of the Patient, Consumer, and Public Health Coalition, we recognize the need for new drugs to reach patients with serious or life-threatening diseases. The pipeline for new antibacterial drugs is shrinking. However, we have grave concerns about proposals to change the standards for meeting FDA’s requirement of two “adequate and well controlled” trials.

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