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This is because off-label use has not undergone the same rigorous testing and clinical trials required for FDA approval, meaning that the risks and benefits have not been fully established

Zhang H, Wu C, Chen Q, Chen X, Xu Z, Wu J, et al

Available safety data comes from animal research, limited clinical trials, and user documentation rather than the rigorous safety evaluation required for approved medications

Doctors and pharmacists use these names when describing the same solution

While the Bridge Program creates an exception, other manufacturer savings programs like NovoCare typically exclude Medicare beneficiaries