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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.

• FY 2010
• FY 2011
• FY 2012
• All

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

Fiscal Year - 2011

Time	Target	Percent
Oct 2010	N/A	50
Nov 2010	N/A	25
Dec 2010	N/A	50
Jan 2011	N/A	50
Feb 2011	N/A	40
Mar 2011	N/A	38
Apr 2011	N/A	40
May 2011	N/A	38
Jun 2011	N/A	33
Jul 2011	N/A	27
Aug 2011	N/A	33
Sep 2011	N/A	73

Percent with analysis datasets available for all primary studies

Fiscal Year - 2011

Time	Target	Percent
Oct 2010	N/A	70
Nov 2010	N/A	88
Dec 2010	N/A	88
Jan 2011	N/A	88
Feb 2011	N/A	70
Mar 2011	N/A	100
Apr 2011	N/A	100
May 2011	N/A	100
Jun 2011	N/A	83
Jul 2011	N/A	91
Aug 2011	N/A	75
Sep 2011	N/A	82

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

Fiscal Year - 2011

Time	Target	Percent
Oct 2010	N/A	20
Nov 2010	N/A	25
Dec 2010	N/A	38
Jan 2011	N/A	13
Feb 2011	N/A	0
Mar 2011	N/A	54
Apr 2011	N/A	20
May 2011	N/A	31
Jun 2011	N/A	67
Jul 2011	N/A	55
Aug 2011	N/A	0
Sep 2011	N/A	64