November 8, 2013. Medical devices should not be approved on the basis of wishful thinking.
Read More »On Health Policy
Comments on the NIH Office of Disease Prevention Strategic Plan for Fiscal Years 2014-2018
November 22, 2013. While improvement in public health measures can be more challenging to assess, and requires a longer time period to evaluate, the goal of prevention research should be focused on measurable health outcomes, and not simply on the number of grants or scientific publications. A more explicit identification and prioritization of research goals would increase confidence that meaningful public health results will be achieved where they are most urgently needed.
Read More »NCHR Comments to FDA on Endocrine Disruption Potential of Drugs
November 20, 2013. We welcome the opportunity to comment on the FDA’s guidance to industry on preclinical detection of endocrine disruption potential in drug and biologics applications.
Read More »Comments on FDA Safety and Innovation Act Section 907 Report
November 20, 2013. The National Research Center for Women & Families strongly supports the requirement of the Food and Drug Administration Safety and Innovation Act (FDASIA) for an action plan to include demographic subgroups in clinical trials and data analysis.
Read More »Letter to FDA Regarding Advisory Committee Panel on Reclassification of CPR Devices
November 5, 2013. We write to express strong concerns about the September 11, 2013 FDA meeting of the Advisory Committee for Circulatory System Devices. This Advisory Committee meeting discussed and made recommendations regarding the proposed down-classification of External Cardiac Compressor (ECC) devices. The panel members were asked to consider the FDA recommendation that ECC devices be reclassified from Class III (high risk) to Class II (moderate risk) with special controls.
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