August 13, 2014. We urge the participating agencies to ensure that NARMS receives the funding that it needs to maintain and build upon these vital efforts. Antibiotic resistant infections are estimated to cost the U.S. healthcare system between $21 and $34 billion dollars every year.
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Statement of Dr. Diana Zuckerman Regarding Deadly Water at Camp Lejeune in North Carolina
August 14, 2014. A new study shows that the contaminated drinking water at USMC Base Camp Lejeune from the 1950s to 1985 was deadly to civilians working there as well as the active military and their family members living there.
Read More »Patient, Consumer, and Public Health Coalition Comments on Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
August 11, 2014. Members of the Patient, Consumer, and Public Health Coalition appreciate the opportunity to comment on the draft guidance for the Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices. The draft guidance states that the use of consensus standards will “streamline premarket review” and “facilitate market entry for safe and effective medical products.” We support a more efficient process, but are concerned about the potential for lowering the standards for safety and effectiveness since the draft guidance states that one of the purposes of declaring conformance with a consensus standard is to “reduce the amount of supporting data and information that are submitted to FDA.”
Read More »Patient, Consumer, and Public Health Coalition Comments on Proposed Rule to Allow FDA to Regulate All Tobacco Products
August 8, 2014. As members of the Patient, Consumer, and Public Health Coalition we are writing to comment on various aspects of the proposed rule to extend FDA’s jurisdiction to tobacco (including made or derived from tobacco) products other than cigarettes, including e-cigarettes. It is essential that the proposed rule be strengthened, since nicotine is highly addictive.
Read More »Comments Opposing FDA’s Draft Guidance On Postmarket Safety And Effectiveness Data For High-Risk Devices
July 24, 2014. As members of the Patient, Consumer, and Public Health Coalition, we are writing to express our strong concerns about the draft guidance for the “Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval.”
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