September 26, 2016. NCHR supports this bill because there is clear scientific evidence that the vast majority of adverse events from medical products are not reported by physicians, and the percentage may be especially low for devices. “Since most devices are allowed to be without any scientific evidence of safety,” Zuckerman points out, “requiring adverse events to be reported by physicians is especially important.”
Read More »On Health Policy
FDA Guidance Would Lower Safety Standards for High-Risk Medical Devices
September 14, 2016. NCHR strongly opposes this draft guidance. It does not enhance FDA’s goal of “protecting and promoting the public health.”
Read More »NCHR Supports FDA’s Guidance on Generic Drug Labeling Safety
September 9, 2016. NCHR supports this draft guidance, which is a step in the right direction for protecting the public health. However, the guidance should be broadened to include all situations, regardless of whether the RLD has been withdrawn. Moreover, to truly ensure that generic drug labels are updated in a timely manner, the FDA needs to finalize the proposed rule, “Supplemental Applications Proposing Labeling Changes For Approved Drugs and Biological Products.
Read More »NCHR Testimony at the FDA’s Public Hearing on Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products
September 13, 2016. NCHR strongly supports the FDA’s regulation of cell and tissue products. The guidances are reasonable. Through regulation the FDA can protect patients and encourage innovation in the development of new treatments based on sound science. However, enforcement will be critical to stop untested and potentially harmful ‘therapies’.
Read More »NCHR Disappointed in Latest FDA-Drug Industry User Fee Agreement
August 22, 2016 Public Comment to FDA: The National Center for Health Research supports more funding for the FDA through PDUFA but warns that the current process focuses too much on speed over safety, leaving patients at risk and consumers without a strong voice in the process.
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