NCHR Author

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.

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.

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.

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

NCHR Comment on Proposed Draft Guidance Relating to Patient Experience Data

March 21, 2019. Patient perspectives and experience are important considerations for medical product development and regulation. Patients, caregivers, and patient and consumer groups can provide a valuable resource for product developers and the FDA. Transparency in how the FDA evaluates and uses proposed draft guidances as well as who and how they are developed will be important if they are to provide meaningful and accurate information about patients.