NCHR Testimony at FDA on ELEVAIR Endobronchial Coil System

June 14, 2018. The pivotal trial does not provide sufficient evidence for effectiveness or safety. Questions about whether the device is effective are exacerbated by the lack of consistency with the crossover data, the differences between US patients and those outside the US, and the lack of blinding. The long-term follow up data are difficult to interpret without controls.

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NCHR Testimony at the FDA about a Circulatory System Device

June 12, 2018. Since it is a high-risk device, the INCRAFT AAA Stent Graft System should be held to a high standard for approval. As you determine whether you have reasonable assurance of this device’s safety and effectiveness, we urge you to consider the benefits and risks for patients.

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NCHR Co-Signs Letter of Support for Patient Advocacy Transparency Act

March 8, 2018 The Honorable Claire McCaskill United States Senate 503 Hart Senate Office Building Washington, DC, 20510 Dear Senator McCaskill: We welcome the Patient Advocacy Transparency Act, which will expand the Physician Payments Sunshine Act to include disclosure of pharmaceutical and medical device company payments to advocacy organizations, professional societies, and other third parties. […]

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