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 »We’re Speaking Out on Health Issues
NCHR scientists and health policy experts provide written and oral statements on a wide range of topics.
Here are many of the ways we have been Speaking Out on Health Policy Issues for the last few years. Whether the topic is legislation intended to cure diseases, proposed bans on BPA or other chemicals that disrupt your hormones, the importance of including women, people of color, and patients over 65 in clinical trials, or many other topics, you’ll gain a better understanding of our evidence-based analyses by reading these letters, statements, and testimony.
Here are the ways we have been Speaking out on Medical Treatments and Products, such as prescription drugs and medical devices that the FDA is considering approving, or is considering taking off the market because of serious risks. Whether the topic is Chantix, Addyi, Yaz, Essure, or medical products you’ve never heard of, you can find out more about what is known and not known about the safety and effectiveness of a wide range of products by looking through this section of our website.
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
Read More »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.
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