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U.S. Department of Health and Human Services

About FDA

The number of written Drug Master File reviews completed by ONDQA during the month

Dictionary: A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more drugs. The information contained in the DMF may be used to support an Investigational New Drug Application (IND) or New Drug Application (NDA). The review of DMFs only occur in conjunction with an IND, NDA, or NDA supplement review.

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/A19
Nov 2010N/A38
Dec 2010N/A30
Jan 2011N/A50
Feb 2011N/A41
Mar 2011N/A31
Apr 2011N/A42
May 2011N/A37
Jun 2011N/A51
Jul 2011N/A30
Aug 2011N/A54
Sep 2011N/A50

FY 2011 Total: 473


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.