Docket Number:
FDA-2013-D-1020
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Veterinary Medicine

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Bioanalytical Method Validation.” This final guidance incorporates public comments to the revised draft published in 2013 as well as the latest scientific feedback concerning bioanalytical method validation and provides the most up-to-date information needed by drug developers to ensure the bioanalytical quality of their data.

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All written comments should be identified with this document's docket number: FDA-2013-D-1020.