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MODIFIED PHASE REMEDY IMPLEMENTATION PLANARBORWAY CORPORATION3593 3651 WASHINGTON streetBOSTON, MASSACHUSETTS 3 2696FEBRUARY 12, 2009February 12, 2009Mr. Richard T. Horn, Sr.; President c/o Delaney
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Start by carefully reviewing the modified Phase IV form.
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It is a modified form used for reporting specific information related to a clinical trial.
The sponsor of the clinical trial is required to file modified phase iv.
Modified phase iv can be filled out electronically through the appropriate regulatory authority's portal.
The purpose of modified phase iv is to provide additional information on safety and efficacy of a drug post-approval.
Information such as adverse events, long-term effects, and patient outcomes must be reported on modified phase iv.
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