Yielding to industry objections, FDA has abandoned its proposed definition for a suspected adverse drug reaction (SADR) in its just-finalized rule on clinical trial safety reporting.
The agency said it agreed with submitted comments that the proposed definition was “too broad and could have a negative impact on clinical trials, IRBs, investigators, signal detection, and drug labeling.”
Additionally, it said that new definitions of related terms should “contribute to harmonization of safety reporting to regulatory authorities worldwide because they are consistent with the concepts and definitions adopted by the ICH E2A guidance and CIOMS.”
In the final rule, significantly revised terms are defined as follows: “Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. (For the purposes of this definition, untoward means unfavorable, negative, or harmful). Suspected adverse reaction means any adverse event for which there is a reasonable possibility that the drug caused the adverse event. 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 implies a lesser degree of certainty about causality than adverse reaction, which means any adverse event caused by a drug.”