About FDA

Percentage of JINAD submissions consisting of protocols without substantial data completed on time

Dictionary: Sponsors may submit data intended to support an application for generic new animal drug approval during the investigation of the generic new animal drug to a JINAD file. A protocol is a plan for conducting a study that fully describes the objective(s), design, methodology, study endpoints, statistical considerations, and organization of a study. The protocol may include plans for presenting study results in the final study report or submitting study results to FDA in electronic format. Acceptable protocols are critical for the generation of quality data used in the determination of the safety and effectiveness of a generic new animal drug.

Note: October 1, 2008 is the effective date of the AGDUFA.

Information is current as of February 28, 2013.

• FY 2010
• FY 2011
• FY 2012
• FY 2013
• All

Footnotes

• This metric is also an Animal Generic Drug User Fee Program performance goal. In the yearly performance report to Congress, performance is reported for a defined fiscal year receipt cohort. The methodology for reporting by fiscal year receipt cohort calculates performance statistics for submissions for the fiscal year FDA received them, regardless of when FDA ultimately acted on or approved the submissions. The data reported here is the measurement of the number of applications reviewed in a given month regardless of the cohort year.

Number of JINAD submissions consisting of protocols without substantial data completed on time

Fiscal Year - 2012

Time	Target	Number
Oct 2011	N/A	2
Nov 2011	N/A	1
Dec 2011	N/A	1
Jan 2012	N/A	2
Feb 2012	N/A	1
Mar 2012	N/A	0
Apr 2012	N/A	0
May 2012	N/A	3
Jun 2012	N/A	1
Jul 2012	N/A	1
Aug 2012	N/A	1
Sep 2012	N/A	1

FY 2012 Total: 14

Number of JINAD submissions consisting of protocols without substantial data completed within the month

Fiscal Year - 2012

Time	Target	Number
Oct 2011	N/A	2
Nov 2011	N/A	1
Dec 2011	N/A	1
Jan 2012	N/A	2
Feb 2012	N/A	1
Mar 2012	N/A	0
Apr 2012	N/A	0
May 2012	N/A	3
Jun 2012	N/A	2
Jul 2012	N/A	1
Aug 2012	N/A	1
Sep 2012	N/A	1

FY 2012 Total: 15