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everyone my name is elizabeth jaquinto friedman and im a regulatory counsel in the division of policy development in the office of generic drug policy today im going to provide an overview on evaluating therapeutic equivalence there are three main learning objectives for this presentation and those objectives are to outline the fundamentals of therapeutic equivalence describe what fda considers in therapeutic equivalence evaluations and describe how fda makes therapeutic equivalence determinations well move right into the fundamentals of therapeutic equivalence drug products that are therapeutic equivalents can be substituted with the full expectation that the substituted product will produce the same clinical effect and safety profile as the prescribed product therapeutic equivalence evaluations are listed in the fda publication approved drug products with therapeutic equivalence evaluations better known as the orange book for multi-source prescription drug products approved under
