The National Center for Health Research supports AHRQ's draft review finding that partial breast irradiation (PBI) is effective for select early-stage breast cancer patients, with most outcomes comparable to whole breast irradiation (WBI) at 5-10 years. NCHR emphasizes the need for additional research on different PBI types and long-term outcomes at 15-20 years, particularly across diverse patient populations.
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NCHR’s Testimony on the FDA’s Proposed Reclassification of Computer-Aided Devices which Provide Adjunctive Diagnostic Information about Lesions Suspicious for Melanoma from Class III Devices to Class II Devices
July 29, 2022. We do not support the proposed reclassification of the two skin lesion analyzers, MelaFind and Nevisense, from Class III to Class II. We have 2 major concerns: There is no guarantee that newly developed devices cleared through the 510(k) process would be as accurate as those currently on the market. For that reason, newly developed devices should be reviewed through the PMA process and there is a clear risk of false positive and false negative results, misuse, and device failure, and the FDA has not provided adequate evidence that these risks can be adequately mitigated with the Class II special and general controls listed in the executive summary. As described, FDA cannot ensure that there will be reasonable assurance of safety or effectiveness over the lifespan of the newly submitted devices.
Read More »NCHR Testimony on NUPLAZID for the Treatment of Alzheimer’s Disease Psychosis
June 17, 2022: In 2018 FDA was concerned about “the numbers of reports of death and other serious adverse events” regarding this drug, which already carries a black box warning that there is “increased mortality in elderly patients with dementia-related psychosis.” To outweigh such serious safety risks, the benefits of this drug would need to be substantial. However, there is no such evidence.
Read More »NCHR’s Testimony to FDA on the Novavax COVID-19 Vaccine
June 7, 2022: While this vaccine demonstrates similar levels of efficacy as compared to vaccines approved for COVID-19, the data suggests additional safety risks. Even if it is not proven to be less safe than the other COVID vaccines, it lacks long-term, placebo-controlled efficacy data and there is very little safety or efficacy data for the most at-risk patients. When we already have vaccines on the market that are FDA approved, and based on much better data, why would the FDA authorize this vaccine?
Read More »NCHR’s Testimony to FDA on End of Induction Response in High-Risk Neuroblastoma
May 12, 2022. Clinical benefits should remain the key endpoints for approval decisions of these treatments. Surrogate endpoints that predict clinical benefits are not yet established and until they are, we are concerned about their use as secondary endpoints unless the primary endpoint is also met.
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