GBCA Sponsors Must Conduct Human, Animal Studies To Assess Safety
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.
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Judge overseeing multidistrict litigation convenes meeting with senior pharma executives, government plaintiffs and others to learn about supply-chain dynamics and other issues to resolve more than 200 suits.
Advisory committee agrees that risks of gadolinium retention in the brain and other organs need further study; actor Chuck Norris' wife was among several patients who testified of devastating medical problems following administration of agents.
US FDA advisory committee to consider whether regulatory actions such as a labeling change are needed and what studies could be done to investigate potential adverse events associated with gadolinium retention in the brain and other body organs.