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Total number of Warning Letters recommendations reviewed in the month

Dictionary: The 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.

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.

• FY 2010
• FY 2011
• All

Number of Seizure actions reviewed in the month

Dictionary: The 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.

Number of Disqualifications reviewed in the month

Dictionary: The 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.

Number of Injunction packages reviewed in the month

Dictionary: The 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.