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 »On Medical Treatments & Products
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 […]
Read More »NCHR Comment on Clinical Evidence for Monoclonal Antibodies to Treat Rabies
April 25, 2019. Monoclonal antibodies to treat rabies exposure could provide a beneficial treatment option, but they need clear and unambiguous evidence of their safety and efficacy.
Read More »Statement on Behalf of Members of the Patient, Consumer, and Public Health Coalition at the FDA Advisory Committee on Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and Informed Consent
March 26, 2019. NCHR testified at the FDA advisory committee meeting on Breast Implants on improving informed consent procedures for informing patients on risks of BIA-ALCL
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