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De Waele K, Ishkanian SL, Bogarin R, Miranda CA, Ghatei MA, Bloom SR, et al

Is there a basis to conclude, for each FDA-approved product that includes the nominated bulk drug substance, that: (a) an attribute of the FDA-approved drug product makes it medically unsuitable to treat certain patients for a condition that FDA has identified for evaluation, and (b) the drug product proposed to be compounded is intended to address that attribute

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