May 27, 2021. FDA scientists note substantial problems with the study sample. These study shortcomings are even more worrisome since the sample was very small.
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NCHR’s Testimony at FDA Regarding Donislecel Treatments for Diabetes
April 15, 2021: We agree with the concerns of the FDA reviewers regarding the benefit-risk profile of donislecel transplant treatments.
Read More »Testimony at FDA on Sotagliflozin to Help Manage Type 1 Diabetes
January 17, 2019. Just providing new treatment options is not enough. New treatments must provide a real tangible benefit for patients without too much risk.
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