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.

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NCHR’s Comments on FDA’s Draft Guidance on Levonorgestrel

March 23, 2020 National Center for Health Research’s Public Comments on FDA’s Draft Guidance on Levonorgestrel [Docket Number FDA-2007-D-0369] We are pleased to have the opportunity to comment on the FDA Draft Guidance on Levonorgestrel IUD devices for the design of bioequivalence studies supporting abbreviated new drug applications.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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