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 Members of the Patient, Consumer, and Public Health Coalition appreciate the opportunity to comment on the draft guidance for the Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices. The draft guidance states that the use of consensus standards will “streamline premarket review” and “facilitate market entry for safe and effective medical products.”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process, but are concerned about the potential for lowering the standards for safety and effectiveness since the draft guidance states that one of the purposes of declaring conformance with a consensus standard is to “reduce the amount of supporting data and information that are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 »On Health Policy
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Read More »Comments Opposing FDA’s Draft Guidance On Postmarket Safety And Effectiveness Data For High-Risk Devices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members of the Patient, Consumer, and Public Health Coalition, we are writing to express our strong concerns about the draft guidance for the “Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval.”
Read More »Patient, Consumer, and Public Health Coalition Comments in Favor of USPSTF Draft Recommendation on Screening for Vitamin D Deficiency
July 30, 2014. Members of the Patient, Consumer, and Public Health Coalition commend the U.S. Preventive Services Task Force (USPSTF) efforts to provide advice based on scientific evidence on screening for vitamin D deficiency in the general adult population.
Read More »Statement of Dr. Diana Zuckerman in Support of the SWEET Act
July 30, 2014. The National Center for Health Research strongly supports the SWEET Act introduced by Representative Rosa DeLauro (D-CT). Today, sugary beverages represent the largest calorie source in an American teen’s diet — and the largest calorie count for many adults as well. The SWEET Act is the first step towards helping curb this trend.
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