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U.S. Department of Health and Human Services

About FDA

Number of Warning Letters issued in the quarter for unapproved drugs that are not part of class actions

Dictionary: The Unapproved Drugs initiative is described in detail on FDA Internet. In removing unapproved drugs from the marketplace, OC may issue a class action to all manufacturers and/or individual actions to individual manufacturers. For the initial version of this measure we are reporting on class actions, as well as other actions such as seizures or injunctions.

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 -Dec 2010N/A0
Jan – Mar 2011N/A0
Apr – Jun 2011N/A4
Jul – Sep 2011N/A0


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.