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<measures><measure><type>Main</type><parent-measure></parent-measure><title>Number of class actions taken in the quarter regarding marketed unapproved drugs</title><dictionary>&lt;a href= http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm118990.htm target=”_blank”&gt;The Unapproved Drugs&lt;/a&gt; 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.</dictionary>
<dictionary>&lt;br&gt;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. &lt;/b&gt;</dictionary>
<measure-description>Number</measure-description><chart-type></chart-type><chart-color></chart-color><right-min></right-min><right-max></right-max><fiscal-year><chart-min>0</chart-min><chart-max></chart-max><title>2010</title><target-header></target-header><target-description></target-description><summary></summary><time><frame>Oct - Dec 2009</frame><target></target><value>1</value></time><time><frame>Jan – Mar 2010</frame><target></target><value>1</value></time><time><frame>Apr – Jun 2010</frame><target></target><value>1</value></time><time><frame>Jul – Sep 2010</frame><target></target><value>1</value></time></fiscal-year><fiscal-year><chart-min>0</chart-min><chart-max></chart-max><title>2011</title><target-header></target-header><target-description></target-description><summary></summary><time><frame>Oct -Dec 2010</frame><target></target><value>0</value></time><time><frame>Jan – Mar 2011</frame><target></target><value>1</value></time><time><frame>Apr – Jun 2011</frame><target></target><value>0</value></time><time><frame>Jul – Sep 2011</frame><target></target><value>0</value></time></fiscal-year></measure><related-links><link><url>http://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htm</url><text>FDA-TRACK CDER Dashboard</text></link></related-links><measure><type>Sub</type><parent-measure>Number of class actions taken in the quarter regarding marketed unapproved drugs</parent-measure><title>Number of products involved in class actions taken in the quarter regarding marketed unapproved drugs</title><dictionary></dictionary><measure-description>Number</measure-description><chart-type></chart-type><chart-color></chart-color><right-min></right-min><right-max></right-max><fiscal-year><chart-min>0</chart-min><chart-max></chart-max><title>2010</title><target-header></target-header><target-description></target-description><summary></summary><time><frame>Oct - Dec 2009</frame><target></target><value>7</value></time><time><frame>Jan – Mar 2010</frame><target></target><value>6</value></time><time><frame>Apr – Jun 2010</frame><target></target><value>1</value></time><time><frame>Jul – Sep 2010</frame><target></target><value>N/A</value></time></fiscal-year><fiscal-year><chart-min>0</chart-min><chart-max></chart-max><title>2011</title><target-header></target-header><target-description></target-description><summary></summary><time><frame>Oct -Dec 2010</frame><target></target><value>N/A</value></time><time><frame>Jan – Mar 2011</frame><target></target><value>496</value></time><time><frame>Apr – Jun 2011</frame><target></target><value>N/A</value></time><time><frame>Jul – Sep 2011</frame><target></target><value>N/A</value></time></fiscal-year></measure><measure><type>Sub</type><parent-measure>Number of class actions taken in the quarter regarding marketed unapproved drugs</parent-measure><title>Number of manufacturers involved in class actions taken in the quarter regarding marketed unapproved drugs</title><dictionary></dictionary><measure-description>Number</measure-description><chart-type></chart-type><chart-color></chart-color><right-min></right-min><right-max></right-max><fiscal-year><chart-min>0</chart-min><chart-max>550</chart-max><title>2010</title><target-header></target-header><target-description></target-description><summary></summary><time><frame>Oct - Dec 2009</frame><target></target><value>4</value></time><time><frame>Jan – Mar 2010</frame><target></target><value>2</value></time><time><frame>Apr – Jun 2010</frame><target></target><value>1</value></time><time><frame>Jul – Sep 2010</frame><target></target><value>N/A</value></time></fiscal-year><fiscal-year><chart-min>0</chart-min><chart-max>550</chart-max><title>2011</title><target-header></target-header><target-description></target-description><summary></summary><time><frame>Oct -Dec 2010</frame><target></target><value>N/A</value></time><time><frame>Jan – Mar 2011</frame><target></target><value>109</value></time><time><frame>Apr – Jun 2011</frame><target></target><value>N/A</value></time><time><frame>Jul – Sep 2011</frame><target></target><value>N/A</value></time></fiscal-year></measure><measure><type>Main</type><parent-measure></parent-measure><title>Number of seizures or injunctions issued in the quarter for unapproved drugs</title><dictionary>&lt;a href= http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm118990.htm target=”_blank”&gt;The Unapproved Drugs&lt;/a&gt; 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.</dictionary><measure-description>Number</measure-description><chart-type></chart-type><chart-color></chart-color><right-min></right-min><right-max></right-max><fiscal-year><chart-min>0</chart-min><chart-max></chart-max><title>2010</title><target-header></target-header><target-description></target-description><summary></summary><time><frame>Oct - Dec 2009</frame><target></target><value>0</value></time><time><frame>Jan – Mar 2010</frame><target></target><value>0</value></time><time><frame>Apr – Jun 2010</frame><target></target><value>2</value></time><time><frame>Jul – Sep 2010</frame><target></target><value>0</value></time></fiscal-year><fiscal-year><chart-min>0</chart-min><chart-max></chart-max><title>2011</title><target-header></target-header><target-description></target-description><summary></summary><time><frame>Oct -Dec 2010</frame><target></target><value>0</value></time><time><frame>Jan – Mar 2011</frame><target></target><value>2</value></time><time><frame>Apr – Jun 2011</frame><target></target><value>0</value></time><time><frame>Jul – Sep 2011</frame><target></target><value>0</value></time></fiscal-year></measure></measures>
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