Percentage of INAD study submissions reviewed within the month that were acted on within 180 days after the submission date
Dictionary: Sponsors may submit data intended to support an application for new animal drug approval during the investigation of the new animal drug to an INAD file. A study submission is a submission containing both the data and conclusions of a study to be considered in support of the approval of a new animal drug. This measure assesses ONADE's timely review and decision making on one aspect of a new animal drug application. (1)
Information is current as of May 31, 2013.
Fiscal Year - 2012
FY 2012 Overall: 100
- (1) This metric is also an Animal 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 INAD study submissions reviewed within the month that were acted upon within 180 days after the submission date
Fiscal Year - 2012
FY 2012 Total: 231
Investigational New Animal Drug
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.