We have new genomic data for a study on a drug that was previously approved. Should we submit it through a VXDS or Biomarker Qualification process?
If the data is a regulatory follow-up of a clinical submission, it needs to be submitted within the original regulatory requirements. If the data was obtained after completing or outside of the regulatory requirements, the exploratory biomarker data are submitted via VXDS process. Data for biomarker qualification should be submitted through the biomarker qualification process. Data for co-development of a test and a drug should follow recommendations in the co-development concept paper Question on Biomarker Terminology and Qualification Since the Guidance for Industry Pharmacogenomics Data Submissions and its Appendix was published in final form in March, 2005, the concept of biological validation for new biomarkers has evolved from exploratory, probable valid, and known valid categorizations in favor of the biological qualification concept as a context dependent, graded evidentiary process linking a biomarker to a specific purpose. When the qualification of biomarkers that would be ap
Related Questions
- We have new genomic data for a study on a drug that was previously approved. Should we submit it through a VXDS or Biomarker Qualification process?
- My study has identified novel insertion sequences and I don have a genomic coordinate for these. How can I submit these to dbVar?
- Can data on genomic biomarker validation be submitted as a VXDS?
