We testified before the FDA Advisory Committee that Pepaxto should no longer be approved for multiple myeloma because new research shows that patients taking it died 5 months sooner than patients taking a different treatment.
Read More »On Medical Treatments & Products
NCHR supports mandatory safety standards for sling baby carriers
September 15, 2022: We are writing to express our views on the Consumer Product Safety Commission’s adoption of a mandatory safety standard for infant sling carriers. We enthusiastically support the plan to make the current CPSC voluntary safety standards – which address product test methods, performance requirements, labeling and instructional literature –mandatory for manufacturers in […]
Read More »Dr. Diana Zuckerman Statement to CDC Advisory Committee On Breast Cancer in Young Women
August 23, 2022: Research shows that many young women are disproportionately afraid of breast cancer and that young breast cancer survivors are more afraid of recurrence than older survivors. I encourage you to think of what we can do together to help reduce that fear so that young women don’t let their fear overwhelm them as they become aware of and educated about their risks as well as their prevention and treatment options.
Read More »NCHR Public Comment on AHRQ Draft Review on Partial Breast Irradiation and Whole Breast Irradiation for Breast Cancer
July 29, 2022 We are writing to express our views on the AHRQ Draft Comparative Effectiveness Review comparing Partial Breast Irradiation (PBI) to Whole Breast Irradiation (WBI) as a treatment for early-stage breast cancer. The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range […]
Read More »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.
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