Number of pharmacometrics IND and NDA/BLA reviews completed per month (1)
Dictionary: These pharmacometrics reviews are a composite number including, but not limited to the following: a) New Drug Application (NDA) or Biologics License Application (BLA) submissions, b) Investigational New Drug (IND) protocol reviews, c) pediatric protocol reviews, d) End-of-Phase 2A (EOP2A) meetings, e) thorough QT (TQT) studies, and f) model reviews. The TQT study determines a drug's effect on cardiac repolarization.
This measure has 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
- (1) PDUFA reviews are captured by OND
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.