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Theyre not typically covered for off-label uses such as weight management
Although extremely costly and time-consuming, these outcome trials have, nevertheless, provided us with extremely valuable information about the natural history of the diseases, drug safety and the influence of the drugs on the disease progression
Increased Risk of Contamination Injectable medications, once punctured, are more vulnerable to bacterial or fungal contamination
Is the potential benefit worth the risk for you
Until the FDA issues specific guidance defining the comparability standard for autologous C&G therapies (a process that will require substantial scientific input from industry, academia, and patient advocacy groups), the BPCIA pathway for C&G therapy biosimilars remains operationally undefined
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