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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3 July, 15:54

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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Luciano Wise · Answer 1

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.