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Federal Register: FDA Finalizes Guidance Governing Therapeutic Equivalence Evaluations For Prescription Drugs
August 23, 2026
WASHINGTON, Aug. 23 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following action in the Federal Register.

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The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry titled "Evaluation of Therapeutic Equivalence." This guidance explains FDA's thinking on therapeutic equivalence evaluations and therapeutic equivalence codes. FDA's therapeutic equiv . . .

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