FDA-TRACK CVM Office of Surveillance and Compliance (OSC) Dashboard

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Contents:

• Key Center Director Measures
• Program Measures
• Key Projects

Note: Information is current as of June 30, 2012.  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.

Key Center Director Measures

Key Center Director Measures are currently under development.  Information will be posted as soon as it is finalized.

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Program Measures

I. Adverse Drug Event or Experience (ADE) Reporting Measures

A. Encourage sponsors, industry, and the public to submit ADE submissions electronically

1. Percentage of electronic ADE submissions

 

II. Warning Letter Review Measures

A. Expedite the CVM review time for warning letters drafted by ORA districts and submitted to CVM for review

1. Number of warning letters received, completed, and pending
2. Average number of days to complete review of warning letters and number of OSC full time employees reviewing warning letters

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Key Projects

I. ADE Reports System Project

A. Develop capability to receive ADE reports electronically 

II. Development of XML Files for Releasable CVM ADE Data Project

A. Provide public access to current CVM ADE data in a harmonized format accessible for data mining technologies

 

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