![]() A suspected adverse reaction implies a lesser degree of certainty about causality than an adverse reaction.Īdverse reaction means any adverse event caused by a drug. For the purposes of IND safety reporting, ‘reasonable possibility’ means there is evidence to suggest a causal relationship between the drug and the adverse event. Suspected adverse reaction means any adverse event for which there is a reasonable possibility that the drug caused the adverse event. ![]() IND application sponsors are required to notify FDA in a written safety report of:Īny adverse experience associated with the use of the drug that is both serious and unexpected orĪny findings from tests in laboratory animals that suggest a significant risk for human subjects including reports of mutagenicity, teratogenicity, and carcinogenicity.Īdverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
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