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
Measure was implemented starting April 2010
| Time | Target | Number |
|---|---|---|
| Apr 2010 | N/A | 9 |
| May 2010 | N/A | 20 |
| Jun 2010 | N/A | 11 |
| Jul 2010 | N/A | 7 |
| Aug 2010 | N/A | 10 |
| Sep 2010 | N/A | 6 |
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
Measure was implemented starting April 2010
| Time | Target | Percent |
|---|---|---|
| Apr 2010 | N/A | 33 |
| May 2010 | N/A | 45 |
| Jun 2010 | N/A | 36 |
| Jul 2010 | N/A | 86 |
| Aug 2010 | N/A | 50 |
| Sep 2010 | N/A | 33 |
Percent with analysis datasets available for all primary studies
Measure was implemented starting April 2010
Fiscal Year - 2010
Measure was implemented starting April 2010
| Time | Target | Percent |
|---|---|---|
| Apr 2010 | N/A | 100 |
| May 2010 | N/A | 95 |
| Jun 2010 | N/A | 82 |
| Jul 2010 | N/A | 100 |
| Aug 2010 | N/A | 100 |
| Sep 2010 | N/A | 83 |
Percent with one or more analysis datasets in Analysis Data Model (ADaM) format
Measure was implemented starting April 2010
Fiscal Year - 2010
Measure was implemented starting April 2010
| Time | Target | Percent |
|---|---|---|
| Apr 2010 | N/A | 22 |
| May 2010 | N/A | 30 |
| Jun 2010 | N/A | 0 |
| Jul 2010 | N/A | 14 |
| Aug 2010 | N/A | 30 |
| Sep 2010 | N/A | 17 |
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.
