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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 - 2012

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TimeTargetNumber
Oct 2011N/A0
Nov 2011N/A1
Dec 2011N/A1
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 2

Number of BLA reviews completed and signed off within the month

Fiscal Year - 2012

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TimeTargetNumber
Oct 2011N/A0
Nov 2011N/A2
Dec 2011N/A2
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 4

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.