Issue Date: May 22, 2018
Issued by: Center for Drug Evaluation and Research
Topic(s): Biopharmaceutics
Status: Final
Bioanalytical Method Validation Guidance for Industry
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.
Download the Guidance Document
