Suspected Adverse Reaction

Any Adverse Event (AE) for which there is a reasonable possibility that the drug caused the AE. For the purposes of IND safety reporting, reasonable possibility means there is evidence to suggest a causal relationship between the drug and the AE. Suspected adverse reaction implies a lesser degree of certainty about causality than Adverse Reaction (AR), which means any AE caused by a drug. FDA: 21 CFR 312.32: IND Safety Reporting; FDA: Safety Reporting Requirements for INDs and BA/BE Studies