MainThe Office of Compliance (OC) is tracking selected examples of enforcement activities performed. Program areas under which enforcement actions may be taken include adverse drug event reporting processes, clinical trials, good manufacturing practices, health fraud, and unapproved new drugs, among others. OC reviews inspections and recommendations for compliance actions to determine if an action is indicated. Warnings letters, seizures, clinical investigator disqualifications, and injunctions are some of the actions we can take or recommend. The measure shows OC's workload and not necessarily how many actions were approved or taken.<br>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. </b> Number0

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Oct 201012Nov 201012Dec 201016Jan 20119Feb 201116Mar 201114Apr 20115May 201119Jun 201120Jul 201110Aug 201117Sep 20119http://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htmFDA-TRACK CDER DashboardMainThe Office of Compliance (OC) is tracking selected examples of enforcement activities performed. Program areas under which enforcement actions may be taken include adverse drug event reporting processes, clinical trials, good manufacturing practices, health fraud, and unapproved new drugs, among others. OC reviews inspections and recommendations for compliance actions to determine if an action is indicated. Warnings letters, seizures, clinical investigator disqualifications, and injunctions are some of the actions we can take or recommend. The measure shows OC's workload and not necessarily how many actions were approved or taken.Number0

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Oct 20100Nov 20100Dec 20103Jan 20110Feb 20110Mar 20110Apr 20111May 20111Jun 20112Jul 20110Aug 20110Sep 20110MainThe Office of Compliance (OC) is tracking selected examples of enforcement activities performed. Program areas under which enforcement actions may be taken include adverse drug event reporting processes, clinical trials, good manufacturing practices, health fraud, and unapproved new drugs, among others. OC reviews inspections and recommendations for compliance actions to determine if an action is indicated. Warnings letters, seizures, clinical investigator disqualifications, and injunctions are some of the actions we can take or recommend. The measure shows OC's workload and not necessarily how many actions were approved or taken.Number0

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Oct 20100Nov 20100Dec 20100Jan 20111Feb 20110Mar 20111Apr 20110May 20111Jun 20110Jul 20111Aug 20110Sep 20110MainThe Office of Compliance (OC) is tracking selected examples of enforcement activities performed. Program areas under which enforcement actions may be taken include adverse drug event reporting processes, clinical trials, good manufacturing practices, health fraud, and unapproved new drugs, among others. OC reviews inspections and recommendations for compliance actions to determine if an action is indicated. Warnings letters, seizures, clinical investigator disqualifications, and injunctions are some of the actions we can take or recommend. The measure shows OC's workload and not necessarily how many actions were approved or taken.Number0

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