April 22, 2020: We commend the assessment of the potential benefits and harms of electrocardiography screening among asymptomatic adults. Furthermore, we applaud the commitment to assessing these potential benefits and harms by subgroups defined by stroke risk, as well as by race/ethnicity, age, and sex.
Read More »On Medical Treatments & Products
NCHR’s Comments on FDA’s Draft Guidance on Levonorgestrel
March 23, 2020: A diverse participant population is necessary for the results to be relevant to women of different races, ethnicities, and BMI.
Read More »NCHR’s comments on FDA’s Draft Guidance for Industry on Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
March, 19, 2020: The FDA’s draft guidance describes circumstances under which exceptions can be made to the requirement of two adequately controlled clinical trials. Although the law allows these exceptions under certain circumstances, we have concerns over the frequency with which these exceptions are made.
Read More »NCHR’s Comments on Cyramza for Metastatic Lung Cancer at FDA Oncologic Drugs Advisory Committee Meeting
February 26, 2020. We oppose approval of this indication of Cyramza without evidence that it improves overall survival enough to outweigh the risk for adverse events and reduced quality of life.
Read More »NCHR’s Testimony to FDA on TOOKAD to Treat Low-Risk Prostate Cancer
February 26, 2020. The long-term complications of TOOKAD to treat low-risk prostate cancer are unclear. We believe that better research needs to be completed before approval, especially because the sponsor did not comply with FDA’s recommendations for the study.
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