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Guidance Issuing OfficeCenter for Drug Evaluation and Research
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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2013-D-1020.