Biomedical Engineering Reference
In-Depth Information
may be considered a serious adverse drug
experience when, based upon appropriate medical
judgment, they may jeopardize the patient or subject
and may require medical or surgical intervention
to prevent one of the outcomes listed in this defi nition.
(
ibid
)
Finally, an unexpected adverse event (UAE) is defi ned by
the FDA as:
. . . any adverse drug experience that is not listed in the
current labeling for the regulated product. This includes
events that may be symptomatically and patho-
physiologically related to an event listed in the labeling,
but differ from the event because of greater severity or
specifi city.
The FDA explains further that:
'Unexpected,' as used in this defi nition, refers to an
adverse drug experience that has not been previously
observed (i.e., included in the labeling) rather than from
the perspective of such experience not being anticipated
from the pharmacological properties of the
pharmaceutical product. (
ibid
)
FDA has provided analogous defi nitions of an AE for other
regulated areas. Moreover, FDA requires “written procedures
for the surveillance, receipt, evaluation, and reporting of
post-marketing AEs.”
23
FDA requires the investigation and
reporting of AEs for many of the areas under its jurisdiction,
as shown in Table 1.6. FDA encourages health care providers
to report any AEs that the providers judge to be clinically
signifi cant.
