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Guidance for industry and FDA staff commercially distributed analyte specific reagents (ASRs), frequ

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Safety : Center for Biologics Evaluation and Research, [2007] 2007

Guidance for industry monoclonal antibodies used as reagents in drug manufacturing.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2001] 2001