Business · 11/08/2011

FDA Releases Guidance on Genomic Biomarker Qualification Submissions

The Food and Drug Administration (FDA) has released a guidance document titled 'E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions' under the International Conference on Harmonisation (ICH), providing recommendations for genomic biomarker qualification submissions to promote consistency across regions and facilitate discussions with regulatory authorities.