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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 - 2010

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TimeTargetNumber
Oct 2009N/A52
Nov 2009N/A32
Dec 2009N/A35
Jan 2010N/A39
Feb 2010N/A27
Mar 2010N/A66
Apr 2010N/A23
May 2010N/A29
Jun 2010N/A45
Jul 2010N/A39
Aug 2010N/A48
Sep 2010N/A55

FY 2010 Total: 490

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.