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Siebel Adverse Events and Complaints Management, MedWatch 3500A Report, Statement of Direction (Doc ID 550034.1)

Last updated on DECEMBER 19, 2019

Applies to:

Siebel Adverse Events and Complaints - Version 7.7.2.6 [18372] to 8.0 [20405] [Release V7 to V8]
Generic (Platform Independent)
Information in this document applies to any platform.

Details

Oracle's Siebel Adverse Events and Complaints Management (AECM) module provides customers with the ability to generate MedWatch 3500A reports for submission to Food and Drug Administration (FDA).

Recent FDA guidelines change the format of the report and also add new reporting elements. The new 3500A report format went into effect on May 01, 2007, and all submissions after that date are required to use the revised format.

Actions

See attached Statement of Direction / Planned Features document for more information.

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