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GBCA Sponsors Must Conduct Human, Animal Studies To Assess Safety

 
• By Michael Cipriano

US FDA is requiring additional safety measures related to GBCAs, but holds that there is no direct relationship established between gadolinium retention and kidney function.

Human kidneys

The US FDA will be requiring manufacturers of gadolinium-based contrast agents (GBCAs) to conduct human and animal studies to further assess their safety amid concerns about the retention of gadolinium in the brain and other body parts, although the agency maintains that there is no clear causal connection between remaining chemical agent and adverse event reports related to kidney function.

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