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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

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 - 2011

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TimeTargetNumber
Oct 2010N/A10
Nov 2010N/A8
Dec 2010N/A8
Jan 2011N/A8
Feb 2011N/A10
Mar 2011N/A13
Apr 2011N/A5
May 2011N/A13
Jun 2011N/A6
Jul 2011N/A11
Aug 2011N/A12
Sep 2011N/A11

FY 2011 Total: 115

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

Fiscal Year - 2011
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TimeTargetPercent
Oct 2010N/A50
Nov 2010N/A25
Dec 2010N/A50
Jan 2011N/A50
Feb 2011N/A40
Mar 2011N/A38
Apr 2011N/A40
May 2011N/A38
Jun 2011N/A33
Jul 2011N/A27
Aug 2011N/A33
Sep 2011N/A73

Percent with analysis datasets available for all primary studies

Fiscal Year - 2011
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TimeTargetPercent
Oct 2010N/A70
Nov 2010N/A88
Dec 2010N/A88
Jan 2011N/A88
Feb 2011N/A70
Mar 2011N/A100
Apr 2011N/A100
May 2011N/A100
Jun 2011N/A83
Jul 2011N/A91
Aug 2011N/A75
Sep 2011N/A82

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

Fiscal Year - 2011
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TimeTargetPercent
Oct 2010N/A20
Nov 2010N/A25
Dec 2010N/A38
Jan 2011N/A13
Feb 2011N/A0
Mar 2011N/A54
Apr 2011N/A20
May 2011N/A31
Jun 2011N/A67
Jul 2011N/A55
Aug 2011N/A0
Sep 2011N/A64

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.