April 15, 2021: We agree with the concerns of the FDA reviewers regarding the benefit-risk profile of donislecel transplant treatments.
Read More »On Medical Treatments & Products
NCHR’s testimony to FDA on the OCS Heart System
April 6, 2021. The materials presented have not proven that the OSC Heart System is as effective or more effective than the usual standard of care.
Read More »NCHR’s Comments to USPSTF on Aspirin to Prevent Morbidity and Mortality from Preeclampsia
March 22, 2021: We support this update, strengthened by new evidence, maintaining the 2014 “B” recommendation that there is moderate certainty of a substantial net benefit for the use of low-dose aspirin as preventive medication after 12 weeks of gestation in women who are at high risk for preeclampsia.
Read More »NCHR’s Testimony to FDA Regarding Tanezumab for Osteoarthritis
March 24, 2021: We agree with the FDA’s assessment that the risk mitigation measures proposed for tanezumab are not likely to be feasible or effective, and there are serious risks, even after patients discontinue use.
Read More »Statement of Diana Zuckerman, Ph.D On Behalf of the National Center for Health Research Before the FDA Advisory Panel Convening to Discuss Dermal Fillers
March 23, 2021: A black box warning is needed, should be prominently displayed, and should include warnings about off-label uses as well as approved indications and well-trained providers.
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