December 18, 2023: NCHR urges the FDA to oppose using non-inferiority trials as evidence for new antibiotic treatments for diabetic foot infections. FDA defines “non-inferior” to include “slightly worse” but new antibiotic treatments should be better than standard treatments. Otherwise they don’t benefit patients and worsen antimicrobial resistance.
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NCHR Comments on FDA’s Proposed Rule Regarding Canned Tuna Standard of Identity and Standard of Fill of Container
November 24, 2023: NCHR urges the FDA to address the issue of methylmercury exposure to children and pregnant women through canned tuna. We urge the FDA to reevaluate current standards and utilize clear labeling to inform consumers of the risk.
Read More »NCHR’s Comments on FDA’s Draft Guidance for Medical Devices with Indications Associated with Weight Loss
November 14, 2023: Medical Devices with indications associated with weight loss that are affected by this FDA draft guidance have many implications for the health and quality of life of many individuals. For this reason, it is vital for FDA guidance to be based on large sample sizes, stringent controls, and extensive follow-up to ensure the safety and efficacy of such medical devices.
Read More »Patient, Consumer, and Public Health Coalition Comments to FDA on their Guidance for Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission
December 6, 2023: In its public comment, members of the Patient, Consumer, Public Health Coalition told FDA that if a predicate device for 510(k) review does not align with the best practices identified in the FDA guidance, the device should be submitted to De novo or PMA instead.
Read More »Featured Presentation by Diana Zuckerman at the CDC Childhood Lead Poisoning Prevention Program Annual Meeting
December 5, 2023: Dr. Diana Zuckerman was the featured speaker at the CDC’s annual childhood lead prevention (CLPPP) meeting in Atlanta, explaining the risks of lead in artificial turf, playground surfaces, recycled rubber tiles, and rubber mulch for plants. Here is her presentation with the photos from her slides.
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