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U.S. Department of Health and Human Services

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Number of written Chemistry, Manufacturing, and Controls (CMC) reviews for Investigational New Drugs (INDs) completed by ONDQA during the month (1)

Dictionary: An IND is an Investigational New Drug Application submitted to the FDA to request permission to conduct U.S. clinical trials using investigational drugs. ONDQA reviews the manufacturing and quality information submitted in new INDs and IND amendments with regards to patient safety and drug development. These reviews include all 30-day safety reviews, reviews of amendments, annual reports, and summary reviews.


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/A142
Nov 2009N/A94
Dec 2009N/A120
Jan 2010N/A115
Feb 2010N/A87
Mar 2010N/A124
Apr 2010N/A145
May 2010N/A123
Jun 2010N/A111
Jul 2010N/A106
Aug 2010N/A120
Sep 2010N/A131

FY 2010 Total: 1,418

Footnotes

  • (1) Includes all 30-day safety reviews, reviews of amendments and annual reports, and summary reviews.

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.