January 17, 2023: NCHR agrees with the FDA’s assessment that certain types of naloxone drug products could be safe and effective for non-prescription use but training is needed to use it correctly in urgent situations. We also support FDA’s request for more research to determine how to provide the most effective instructions and labeling for non-prescription naloxone products.
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NCHR Comments on the Consumer Product Safety Commission’s Proposed Ruling of Safety Standards for Adult Portable Bed Rails
January 9, 2023: NCHR strongly agrees with CPSC’s proposed ruling that APBR has an “unreasonable risk of injury and death associated with entrapment hazards” and enthusiastically supports CPSC’s plan to make the voluntary safety standards mandatory, include new requirements for testing and labeling, and consider banning the products if the new standards do not substantially improve their safety. It is important to consider alternatives to APBR’s if it becomes necessary to ban them, and alternatives can be bed trapezes, adjustable beds, nonslip mattress pads, and bed exit alarms.
Read More »NCHR Testifies Before Cardiovascular and Renal Drugs Advisory Committee on Heart Failure Drug
Dr. Ealena Callender of National Center for Health Research tells Dec. 2022 FDA Advisory Committee to require better research on OM heart failure drug due to lack of evidence of efficacy and concerns about safety due to toxicity.
Read More »NCHR urges FDA to require more diversity in trials to improve accuracy of pulse ox devices
December 2, 2022: NCHR testified at an FDA meeting that there is strong evidence that commonly-used pulse oximeters are less reliable for patients with pigmented skin. The FDA’s current guidelines do not require product labeling to address the impact of skin pigmentation on pulse oximetry. While labeling is important to alert users to possible inaccuracies, it does not diminish the importance of developing devices that are effective for everyone.
Read More »National Center for Health Research Comment on Proposed Labeling Recommendations for Patients Considering LASIK
November 25, 2022: NCHR does not support nonbinding FDA LASIK guidance saying it is not enforceable and does not protect patients. We strongly urge the FDA to require patients to be provided with short, easy-to-understand labeling prior to scheduling surgery, and that the FDA improve their example of a LASIK Patient Checklist to provide more balanced information about risks.
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