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# Guide on Bioanalytical Method Validation
- URL: https://www.fdaweb.com/guide-on-bioanalytical-method-validation-3/
- Published: 2018-05-22T12:00:00.000Z
- Updated: 2026-09-15T00:06:43.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141507

*Federal Register* notice: FDA has made available a guidance entitled “Bioanalytical Method Validation.” The document incorporates public comments to a revised 2013 draft as well as the latest scientific feedback concerning bioanalytical method validation. It is intended to provide the most up-to-date information needed by drug developers to ensure the bioanalytical quality of their data. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-05-22/pdf/2018-10926.pdf?ref=fdaweb.com).