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WEDNESDAY, NOVEMBER 25, 2009
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FDA releases draft IT plan.(IT/electronic records)(Food and Drug Administration)(Information Technology)

Article from: Adverse Event Reporting News Article date: January 15, 2008

FDA has released for public comment its Prescription Drug User Fee Act IV Information Technology Plan.

The agency's intent is to provide regulated industry and other stakeholders with information on its vision for improving the automation of business processes and maintaining IT systems that support the review of human drug applications.

The Food and Drug Administration Amendments Act of 2007 that reauthorized the Prescription Drug User Fee Act also includes IT goals to support upgrading FDA's drug safety program in four ...

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