July 14, 2020: Based on the data discussed today, it is difficult to determine how well Belantamab Mafodotin works and whether its effect is clinically meaningful. To approve a treatment for which the benefits do not clearly outweigh the risks creates additional risk for those who are already suffering.
Read More »On Medical Treatments & Products
NCHR Comments on Laparoscopic Power Morcellators
April 27, 2020. We are disappointed that the FDA’s plan to update the 2014 recommendations for the labeling of laparoscopic power morcellators (LPMs) does not adequately strengthen the warnings.
Read More »NCHR’s Public Comments on the USPSTF Draft Research Plan on Atrial Fibrillation: Screening With Electrocardiography
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Read More »NCHR’s Comments on FDA’s Draft Guidance on Levonorgestrel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Read More »NCHR’s comments on FDA’s Draft Guidance for Industry on Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
March, 19, 2020: The FDA’s draft guidance describes circumstances under which exceptions can be made to the requirement of two adequately controlled clinical trials.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.
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