Federal Register #FDA-2022-D-0528

FDA Final Guidance on Evaluation of Therapeutic Equivalence for Industry

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has issued a final guidance document for industry regarding the evaluation of therapeutic equivalence for multisource prescription drug products. - Government Buyer: - Food and Drug Administration (FDA) - Department of Health and Human Services - Purpose: - Provides FDA's approach to evaluating therapeutic equivalence - Details assignment of therapeutic equivalence codes (TE codes) for multisource prescription drugs - Guidance applies to products approved under the Federal Food, Drug, and Cosmetic Act - Publication: - Evaluations and TE codes are published in the Orange Book - Intended to inform prescribers, pharmacists, state health agencies, and the public - Notable Requirements: - Updates process for requesting TE codes for certain drug applications - Finalizes previous draft guidance - No procurement activity: - No OEMs or vendors mentioned - No products or services requested - No unique procurement requirements - This is an informational guidance release, not a solicitation or award.

Description

The Food and Drug Administration (FDA) has announced the availability of a final guidance for industry titled "Evaluation of Therapeutic Equivalence." This guidance explains FDA's approach to therapeutic equivalence evaluations and therapeutic equivalence codes (TE codes) for multisource prescription drug products approved under the Federal Food, Drug, and Cosmetic Act. The evaluations are listed in the Orange Book and serve as public information to aid prescribers, pharmacists, and state health agencies in drug product selection and healthcare cost containment. The guidance finalizes the draft issued in July 2022 and includes updates to the process for requesting TE codes for certain applications.

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