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Number of voluntary exploratory data submissions (VXDS) and biomarker qualification reviews completed per month (1)

Dictionary: Voluntary Exploratory Data Submissions (VXDSs) [formerly Voluntary Genomic Data Submissions (VGDSs)] are non-regulatory exchanges between the FDA and the pharmaceutical industry of scientific and clinical information about new biomarkers in drug development. These submissions are extremely valuable to maintain knowledge about these biomarkers and the measurement and analysis platforms required to interpret the results of their application. These submissions also help train reviewers for the eventual application of these biomarkers in INDs, NDAs and BLAs. Over the past year, we have observed a stable number of new VXDS in line with the annual average of 5 we have had over the past 7 years, while the regulatory application of the types of biomarkers introduced through VXDS has increased 250% year-to-year. The current level of regulatory reviews with genomic data is a good indicator of the success of VXDS meetings. The Biomarker Qualification Process was initiated as a Pilot in 2006 and became a permanent regulatory process in 2009. The goals of the Biomarker Qualification Process are to qualify biomarkers for which enough data are available to support their use in drug development and regulatory review, and to accelerate their application and the development of new biomarkers.

This measure has been retired as CDER has created new measures for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research.

• FY 2010
• All

Footnotes

• (1) PDUFA reviews are captured by OND