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Initial Reporting
Initial Reporting
IND application sponsor must report any suspected adverse reaction or adverse reaction to study treatment that is both serious and unexpected.
Unexpected serious suspected adverse reactions and observations from animal studies suggesting significant risk to human subjects must be reported to FDA as soon as possible but no later than within 15 calendar days following the sponsor’s initial receipt of the information.
Unexpected fatal or life-threatening suspected adverse reactions represent especially important safety information and must be reported to FDA as soon as possible but no later than 7 calendar days following the sponsor’s initial receipt of the information.