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U.S. Department of Health and Human Services

About FDA

Number of Incoming New Drug Applications (NDAs), Biologics License Applications (BLAs), and Efficacy Supplements with electronic datasets received

Measure was implemented starting April 2010

Dictionary: To efficiently and effectively review the results of clinical trials submitted for NDAs, BLAs and Efficacy Supplements, statistical reviewers in CDER need electronic datasets from the studies conducted by industry. Beginning in 2004, under the auspices of The Critical Path Initiative, the Agency recommended that sponsors voluntarily use standards developed by the Clinical Data Interchange Standards Consortium (CDISC) to describe and format these studies. Using datasets based on the Study Data Tabulation Model (SDTM) and derived variables described by Analysis Data Model (ADaM) standards, CDER reviewers can use powerful tools, techniques and software to perform their evaluations. These standards can improve the efficiency and quality of CDER’s review processes and thereby meet the expectations of CDER’s 21st Century Review Initiative. These metrics measure the progress of our efforts to encourage industry to submit standards-based electronic datasets needed for the timely, high quality review of clinical trials.


These measures have 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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Measure was implemented starting April 2010

TimeTargetNumber
Apr 2010N/A9
May 2010N/A20
Jun 2010N/A11
Jul 2010N/A7
Aug 2010N/A10
Sep 2010N/A6

Percent with data tabulations in Study Data Tabulation Model (SDTM) format for one or more primary studies

Measure was implemented starting April 2010

Fiscal Year - 2010
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Measure was implemented starting April 2010

TimeTargetPercent
Apr 2010N/A33
May 2010N/A45
Jun 2010N/A36
Jul 2010N/A86
Aug 2010N/A50
Sep 2010N/A33

Percent with analysis datasets available for all primary studies

Measure was implemented starting April 2010

Fiscal Year - 2010
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Measure was implemented starting April 2010

TimeTargetPercent
Apr 2010N/A100
May 2010N/A95
Jun 2010N/A82
Jul 2010N/A100
Aug 2010N/A100
Sep 2010N/A83

Percent with one or more analysis datasets in Analysis Data Model (ADaM) format

Measure was implemented starting April 2010

Fiscal Year - 2010
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Measure was implemented starting April 2010

TimeTargetPercent
Apr 2010N/A22
May 2010N/A30
Jun 2010N/A0
Jul 2010N/A14
Aug 2010N/A30
Sep 2010N/A17

Glossary

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.