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Warning Label For Gadolinium Contrast Agents Gets US FDA Panel Backing

 
• By Brenda Sandburg

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.

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A US FDA advisory committee agreed with the agency's plan to add a warning to the labeling of gadolinium-based contrast agents about the potential consequences of gadolinium retention in the brain and other body organs.

The agency has concluded that a causal connection has not been established between gadolinium retention and reported symptoms in patients...

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US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
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The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.