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# Therapeutic Equivalence Evaluation Guidance
- URL: https://www.fdaweb.com/therapeutic-equivalence-evaluation-guidance/
- Published: 2022-07-20T12:00:00.000Z
- Updated: 2026-09-14T17:52:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152318

FDA has published a draft guidance, *Evaluation of Therapeutic Equivalence*, explaining the agency’s therapeutic equivalence evaluations, including the assignment of therapeutic equivalence codes. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/evaluation-therapeutic-equivalence?utm%5Fmedium=email&utm%5Fsource=govdelivery) says FDA’s therapeutic equivalence evaluations are listed for multisource prescription drug products approved under Section 505 of the Federal Food, Drug, and Cosmetic Act (FFDCA) in the active section of the *Orange Book*.

“Therapeutic equivalence evaluations are a scientific judgment based upon evidence, while generic substitution may involve social and economic policy administered by the states, e.g., reducing the cost of drugs to consumers,” the draft says. “These evaluations do not constitute determinations that any product is in violation of the FFDCA or that any product is preferable to any other.”