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U.S. Department of Health and Human Services

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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 - 2011

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Oct 2010N/A38
Nov 2010N/A26
Dec 2010N/A35
Jan 2011N/A48
Feb 2011N/A28
Mar 2011N/A34
Apr 2011N/A38
May 2011N/A45
Jun 2011N/A35
Jul 2011N/A21
Aug 2011N/A50
Sep 2011N/A41

FY 2011 Total: 439


  • (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.