We share the concerns of the FDA scientists that trends shown by the data do not support the claim that TRELEGY improves all-cause mortality.
Read More »On Medical Treatments & Products
NCHR’s Testimony to FDA on Belantamab Mafodotin
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 »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
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Read More »NCHR’s Comments on FDA’s Draft Guidance on Levonorgestrel
March 23, 2020 National Center for Health Research’s Public Comments on FDA’s Draft Guidance on Levonorgestrel [Docket Number FDA-2007-D-0369] We are pleased to have the opportunity to comment on the FDA Draft Guidance on Levonorgestrel IUD devices for the design of bioequivalence studies supporting abbreviated new drug applications. The National Center for Health Research (NCHR) is […]
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