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U.S. Department of Health and Human Services

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Number of NDA reviews completed and signed off within the month

Dictionary: Number of NDA and BLA reviews, for therapeutic protein and monoclonal antibody products, completed and signed off by OBP within the month. Includes all initial quality assessment (IQA) reviews, primary reviews, summary and executive reviews. These reviews evaluate the manufacturing and quality of products for marketing approval. These reviews cover quality related aspects of safety including immunogenicity.


These measures have 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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TimeTargetNumber
Oct 2010N/A3
Nov 2010N/A3
Dec 2010N/A6
Jan 2011N/A1
Feb 2011N/A1
Mar 2011N/A0
Apr 2011N/A6
May 2011N/A2
Jun 2011N/A1
Jul 2011N/A0
Aug 2011N/A0
Sep 2011N/A1

FY 2011 Total: 25

Number of BLA reviews completed and signed off within the month

Fiscal Year - 2011

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TimeTargetNumber
Oct 2010N/A0
Nov 2010N/A2
Dec 2010N/A0
Jan 2011N/A0
Feb 2011N/A3
Mar 2011N/A3
Apr 2011N/A3
May 2011N/A1
Jun 2011N/A1
Jul 2011N/A6
Aug 2011N/A2
Sep 2011N/A1

FY 2011 Total: 22

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.