May 9, 2018. It is uncertain if the benefits outweigh the risks based on the data discussed today. However, there should be sufficient evidence of both safety and efficacy before approval.
Read More »On Medical Treatments & Products
NCHR Report: The Health Risks of MRIs with Gadolinium-Based Contrast Agents
Gadolinium-based contrast agents can improve the diagnostic accuracy of MRIs, however gadolinium can stay in the body for months or years. There are many unanswered questions about who develops health problems related to gadolinium, how to determine if symptoms are due to gadolinium, and how to prevent or treat gadolinium-related conditions.
Read More »NCHR Public Comment to FDA on breast implant safety
April 26, 2019. NCHR submitted a comment to the FDA regarding the safety of breast implants, making suggestions for patient checklists, registry changes, and more.
Read More »NCHR Testimony on the safety and effectiveness of bacitracin for intramuscular injection for the treatment of infants with pneumonia
April 26, 2019. Not requiring scientific evidence to keep this product on the market would set a terrible precedent, and other companies would demand the same treatment. We urge the committee to prevent that precedent by voting to rescind approval of IM bacitracin until data are submitted establishing its benefits for another indication.
Read More »Public Comments by Women’s Health Experts on General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting
National Center for Health Research Public Comment on General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. Thank you for the opportunity to provide comments on FDA’s General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. We are writing on behalf of five […]
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