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U.S. Department of Health and Human Services

About FDA

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.

Fiscal Year - 2010

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Oct 2009N/A2
Nov 2009N/A1
Dec 2009N/A1
Jan 2010N/A2
Feb 2010N/A0
Mar 2010N/A0
Apr 2010N/A0
May 2010N/A0
Jun 2010N/A2
Jul 2010N/A1
Aug 2010N/A0
Sep 2010N/A0


  • (1) PDUFA reviews are captured by OND


Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.