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FDA Medical Imaging Drugs Advisory Committee

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Executive Summary

Will meet Nov. 7 to review Bristol-Myers Squibb's NDA (20-131) for Prohance (gadoteradol), and a proposal for limited range of contrast media concentrations. On Nov. 8, the committee will discuss Sterling's NDA (20-123) for gadodiamide, a non-ionic gadolinium contrast agent for MRI imaging of the central nervous system, and a Nuclear Regulatory Commission update. Meeting will begin at 8:30 a.m. each day at the Marriott Hotel, 620 Perry Parkway, Gaithersburg, Md....

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