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24 June, 07:04

The sponsor must submit an ind safety report to the fda if an adverse event is (1) serious; (2) unexpected; and:

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  1. 24 June, 08:13
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    The likely reason of a sponsor to submit an IND safety report to the fda if such adverse events occurs. These may include of events of being unexpected, serious and that there is a presence of suspected adverse reaction in which is likely to be a way of submitting a safety report.
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