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<measures><measure><type>Main</type><parent-measure></parent-measure><title>Number of PMRs and PMCs established during the month</title><dictionary>&lt;a href= http://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm target=”_blank”&gt;Postmarket Requirements (PMR) and Commitments (PMC)&lt;/a&gt; are required or agreed-upon studies or trials conducted after the approval of a marketing application. The number of PMRs and PMCs established during the month reflect the number of postmarket studies or trials required for safety or requested by FDA, while the number of PMRs and PMCs fulfilled or released during the month reflects the combined total number of studies or trials fulfilled/released by both CDER and CBER in response to the required or requested PMRs and PMCs.</dictionary>
<dictionary>&lt;br&gt;These measures 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. &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></chart-min><chart-max></chart-max><title>2010</title><target-header></target-header><target-description>Measure was implemented starting October 2010</target-description><summary></summary><time><frame>Oct 2009</frame><target></target><value>N/A</value></time><time><frame>Nov 2009</frame><target></target><value>N/A</value></time><time><frame>Dec 2009</frame><target></target><value>N/A</value></time><time><frame>Jan 2010</frame><target></target><value>N/A</value></time><time><frame>Feb 2010</frame><target></target><value>N/A</value></time><time><frame>Mar 2010</frame><target></target><value>N/A</value></time><time><frame>Apr 2010</frame><target></target><value>N/A</value></time><time><frame>May 2010</frame><target></target><value>N/A</value></time><time><frame>Jun 2010</frame><target></target><value>N/A</value></time><time><frame>Jul 2010</frame><target></target><value>N/A</value></time><time><frame>Aug 2010</frame><target></target><value>N/A</value></time><time><frame>Sep 2010</frame><target></target><value>N/A</value></time></fiscal-year><fiscal-year><chart-min></chart-min><chart-max></chart-max><title>2011</title><target-header></target-header><target-description></target-description><summary>FY 2011 Total: 351</summary><time><frame>Oct 2010</frame><target></target><value>49</value></time><time><frame>Nov 2010</frame><target></target><value>23</value></time><time><frame>Dec 2010</frame><target></target><value>2</value></time><time><frame>Jan 2011</frame><target></target><value>24</value></time><time><frame>Feb 2011</frame><target></target><value>16</value></time><time><frame>Mar 2011</frame><target></target><value>39</value></time><time><frame>Apr 2011</frame><target></target><value>38</value></time><time><frame>May 2011</frame><target></target><value>48</value></time><time><frame>Jun 2011</frame><target></target><value>37</value></time><time><frame>Jul 2011</frame><target></target><value>29</value></time><time><frame>Aug 2011</frame><target></target><value>36</value></time><time><frame>Sep 2011</frame><target></target><value>10</value></time></fiscal-year><fiscal-year><chart-min></chart-min><chart-max>60</chart-max><title>2012</title><target-header></target-header><target-description></target-description><summary>FY 2012 YTD: 54</summary><time><frame>Oct 2011</frame><target></target><value>22</value></time><time><frame>Nov 2011</frame><target></target><value>25</value></time><time><frame>Dec 2011</frame><target></target><value>7</value></time><time><frame>Jan 2012</frame><target></target><value></value></time><time><frame>Feb 2012</frame><target></target><value></value></time><time><frame>Mar 2012</frame><target></target><value></value></time><time><frame>Apr 2012</frame><target></target><value></value></time><time><frame>May 2012</frame><target></target><value></value></time><time><frame>Jun 2012</frame><target></target><value></value></time><time><frame>Jul 2012</frame><target></target><value></value></time><time><frame>Aug 2012</frame><target></target><value></value></time><time><frame>Sep 2012</frame><target></target><value></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>Main</type><parent-measure></parent-measure><title>Number of PMRs and PMCs fulfilled or released during the month</title><dictionary>&lt;a href= http://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm target=”_blank”&gt;Postmarket Requirements (PMR) and Commitments (PMC)&lt;/a&gt; are required or agreed-upon studies or trials conducted after the approval of a marketing application. The number of PMRs and PMCs established during the month reflect the number of postmarket studies or trials required for safety or requested by FDA, while the number of PMRs and PMCs fulfilled or released during the month reflects the combined total number of studies or trials fulfilled or released by both CDER and CBER in response to the required or requested PMRs and PMCs.</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></chart-min><chart-max></chart-max><title>2010</title><target-header></target-header><target-description>Measure was implemented starting April 2010</target-description><summary></summary><time><frame>Oct 2009</frame><target></target><value>N/A</value></time><time><frame>Nov 2009</frame><target></target><value>N/A</value></time><time><frame>Dec 2009</frame><target></target><value>N/A</value></time><time><frame>Jan 2010</frame><target></target><value>N/A</value></time><time><frame>Feb 2010</frame><target></target><value>N/A</value></time><time><frame>Mar 2010</frame><target></target><value>N/A</value></time><time><frame>Apr 2010</frame><target></target><value>8</value></time><time><frame>May 2010</frame><target></target><value>14</value></time><time><frame>Jun 2010</frame><target></target><value>13</value></time><time><frame>Jul 2010</frame><target></target><value>19</value></time><time><frame>Aug 2010</frame><target></target><value>16</value></time><time><frame>Sep 2010</frame><target></target><value>3</value></time></fiscal-year><fiscal-year><chart-min></chart-min><chart-max></chart-max><title>2011</title><target-header></target-header><target-description></target-description><summary>FY 2011 Total: 189</summary><time><frame>Oct 2010</frame><target></target><value>20</value></time><time><frame>Nov 2010</frame><target></target><value>22</value></time><time><frame>Dec 2010</frame><target></target><value>11</value></time><time><frame>Jan 2011</frame><target></target><value>12</value></time><time><frame>Feb 2011</frame><target></target><value>15</value></time><time><frame>Mar 2011</frame><target></target><value>15</value></time><time><frame>Apr 2011</frame><target></target><value>14</value></time><time><frame>May 2011</frame><target></target><value>14</value></time><time><frame>Jun 2011</frame><target></target><value>18</value></time><time><frame>Jul 2011</frame><target></target><value>13</value></time><time><frame>Aug 2011</frame><target></target><value>17</value></time><time><frame>Sep 2011</frame><target></target><value>18</value></time></fiscal-year><fiscal-year><chart-min></chart-min><chart-max>30</chart-max><title>2012</title><target-header></target-header><target-description></target-description><summary>FY 2012 YTD: 21</summary><time><frame>Oct 2011</frame><target></target><value>8</value></time><time><frame>Nov 2011</frame><target></target><value>2</value></time><time><frame>Dec 2011</frame><target></target><value>11</value></time><time><frame>Jan 2012</frame><target></target><value></value></time><time><frame>Feb 2012</frame><target></target><value></value></time><time><frame>Mar 2012</frame><target></target><value></value></time><time><frame>Apr 2012</frame><target></target><value></value></time><time><frame>May 2012</frame><target></target><value></value></time><time><frame>Jun 2012</frame><target></target><value></value></time><time><frame>Jul 2012</frame><target></target><value></value></time><time><frame>Aug 2012</frame><target></target><value></value></time><time><frame>Sep 2012</frame><target></target><value></value></time></fiscal-year><footnotes><note>Data reflects the combined total number of PMRs and PMCs fulfilled or received by both CDER and CBER.</note></footnotes></measure></measures>
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