Gadavist Dosing Complexities To Be Handled With Packaging, Not REMS
This article was originally published in The Pink Sheet Daily
Bayer's newly approved gadolinium-based contrast agent only needs half the dose of other such products. The label eschews comparative safety claims.
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FDA advisory committee scheduled for Valentine’s Day is key test for Guerbet’s efforts to get its MRI imaging agent a wider indication than Bayer’s Gadavist.
Instead of requiring sponsors to conduct a study, the agency is providing grant to the University of Pittsburgh Medical Center to create a prospective registry that will examine the relationship between exposure to gadolinium-based contrast agents and nephrogenic systemic fibrosis.