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Animal & Veterinary

FDA Issues Guidance Recommending Global Standards for Bioequivalence Study

UPDATED December 15, 2016: The FDA has issued the final version of Guidance for Industry #224 Bioequivalence: Blood Level Bioequivalence Study.

September 23, 2014

The U.S. Food and Drug Administration issued a draft guidance today that, when finalized, will help standardize the data recommendations associated with in vivo blood level bioequivalence (BE) for veterinary pharmaceutical products. Specifically, draft GFI #224: Bioequivalence: Blood Level Bioequivalence Study would create a harmonized definition of bioequivalence, list factors that should be considered when developing scientifically sound blood level bioequivalence study designs, and provide information that should be included in a blood level BE study report.

GFI #224 supports FDA’s work with the Veterinary International Conference on Harmonization (VICH), an international program aimed at harmonizing technical requirements for veterinary product regulation.

The FDA is accepting public comments on this draft guidance beginning September 24, 2014. To submit your comments electronically to the docket, go to and type FDA-2014-D-1352 in the search box. Please note that the docket will not be open to accept comments until this date. The comment period will close 60 days after publication in the Federal Register. While comments are welcome at any time, you should submit them by the closing date for the FDA to consider your comments in drafting the final guidance.

To submit your comments to the docket by mail, use the following address. Be sure to include docket number FDA-2014-D-1352 on each page of your written comments.

The Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Contact FDA

240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

7519 Standish Place, HFV-1

Rockville, MD 20855

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