| Date | Title of guidance and link to document | Type and level of guidance | About the guidance |
|---|---|---|---|
| 10 Apr 2026 | Bioanalytical Method Validation for Biomarkers | Final, Level 2 | This guidance helps sponsors of INDs and applicants of NDAs, BLAs, and NDA and BLA supplements as well as ANDAs, as applicable, to validate bioanalytical methods used to evaluate biomarker concentrations. This guidance can also inform the development of bioanalytical methods used for the analysis of biomarker concentrations in nonclinical study samples. The recommendations in this guidance pertain only to the validation of bioanalytical assays to measure in vivo biomarker concentrations in biological matrices such as blood or urine. This guidance does not apply to bioanalytical method validations for the measurement of veterinary drug concentrations or veterinary biomarker concentrations. |
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