From QIBA Wiki
As content accumulates, we can think about appropriate organization.
- Guidance for Industry, Standards for Clinical Trial Imaging Endpoints, Food and Drug Administration, August 2011.
- Guidance for Industry, E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions, Food and Drug Administration, August 2011.
- Guideline on Clinical Evaluation of Diagnostic Agents, European Medicines Agency, July 2009.