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U.S. Department of Health and Human Services

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Number of genomics Investigational New Drug (IND) and New Drug Application (NDA)/Biologics License Application (BLA) reviews completed per month (1)

Dictionary: These totals reflect a composite number of genomic reviews completed per month for submissions including, but not limited to the following: a) Investigational New Drug (IND) submissions (including protocols, meeting packages, and clinical study reports), b) Biologics License Application (BLA) submissions, c) New Drug Application (NDA) submissions (including original applications, supplements, and post-marketing commitment/requirement reports), and d) Investigational Device Exemptions (IDEs).


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

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TimeTargetNumber
Oct 2009N/A13
Nov 2009N/A14
Dec 2009N/A8
Jan 2010N/A10
Feb 2010N/A5
Mar 2010N/A21
Apr 2010N/A19
May 2010N/A13
Jun 2010N/A10
Jul 2010N/A18
Aug 2010N/A5
Sep 2010N/A5

Footnotes

  • (1) PDUFA reviews are captured by OND

Glossary

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.