U.S. Department of Health and Human Services / office of Communication / Outreach and Development / Food and Drug Administration Center for Drug Evaluation and Research / Food and Drug Administration / Food and Drug Administration Division of Drug Information / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / HFM-40 Center for Biologics Evaluation / European Union / Communications Center for Drug Evaluation / ICH Steering Committee / Center for Biologics Evaluation and Research / / /
Guidance for Industry E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification