January 17, 2012. As members of the Patient, Consumer, and Public Health Coalition, we strongly oppose the reclassification of External Pacemaker Pulse Generator Devices (Product code DTE) from class III (high risk devices) to class II (moderate risk devices). These devices are among the “pre-amendment” class III devices, which have been cleared by the less-than rigorous 510(k) process. External Pacemaker Pulse Generator Devices should remain class III devices and they should require Premarket Approval Applications (PMAs) because they are life-sustaining devices.
Read More »On Health Policy
Letter to Dr. Margaret Hamburg, FDA Commissioner, Regarding Maintaining and Strengthening Conflict of Interest Policies for Advisory Committees
August 3, 2011. In this letter to FDA Commissioner, Dr. Margaret Hamburg, NRC and other coalition members advocate for stronger conflict of interest requirements for members of FDA advisory committees to protect patients and consumers against industry biases.
Read More »Keeping Safeguards That Protect Our Health
November 29, 2011. NCHR signs on to a letter opposing the Regulatory Accountability Act (RAA) (H.R. 3010/S. 1606) and the Regulations from the Executive in Need of Scrutiny (REINS) Act of 2011 (H.R. 10/S. 299) to protect a safe food supply, clean air and water, and a variety of consumer protections for American families.
Read More »NCHR Testimony at the Public Meeting on Prescription Drug User Fee Act (PDUFA) Reauthorization
October 5, 2011. “Everyone in this room agrees that we want safe and effective drugs to be on the market in the U.S. as soon as possible. Where we don’t always agree, however, is what is appropriate evidence of what is safe or effective, and how to weigh the potential risks and potential benefits.”
Read More »Institute of Medicine Report: Medical Devices Lack Evidence of Safety and Effectiveness
July 29, 2011. The prestigious Institute of Medicine (IOM) released a report on the Food and Drug Administration’s 510(k) medical device clearance process stating the system is “flawed” and should be revised. The report echoes the National Research Center for Women & Families’ concerns about the lack of evidence that these devises actually work and are safe.
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