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Evaluation of Therapeutic Equivalence July 2022


Not for implementation. Contains non-binding recommendations.

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The draft guidance explains the criteria FDA uses to evaluate the therapeutic equivalence (TE) of drug products and what the TE codes indicate. The guidance explains how FDA evaluates drug products for, and determines TE for, multi-source drug products to be listed in the Approved Drug Products With Therapeutic Equivalence Evaluations publication (the Orange Book). The guidance provides background on the fundamentals of TE and utilizes a question and answer format to provide more information on the therapeutic equivalence evaluation of approved drug products and assignment of TE codes in the Orange Book.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-0528.

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