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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
II. Warning Letter Review Measures
A. Expedite the CVM review time for warning letters drafted by ORA districts and submitted to CVM for review
- Number of warning letters received, completed, and pending
- Average number of days to complete review of warning letters and number of OSC full time employees reviewing warning letters
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
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