Framework for continuous improvement - Quality Assurance - page 22

Table 1.6 FDA predicate rules for adverse events

Regulated Area Regulation

Animal drugs 21 CFR 514.80

Biologics 21 CFR 600.14, §600.80

Blood processing 21 CFR 606.171

GCP 21 CFR 310.305

GMP 21 CFR 211.198

GTP 21 CFR 1271.350(k)

Medical Devices 21 CFR 803.10

In a typical case, an AE report is initially recorded in the
organization's drug safety information system within a
specifi ed period of time after receipt of the report (say one
day). That record should include the name and title of the
reporter (i.e., typically the health care provider), contact
information for the reporter, the product in question
including label information, and the patient's identifi er. 24 A
medical reviewer gives a preliminary judgment of the
etiology, the “expectedness,” and the severity of the AE, and
provides a medical code for the event based on the Medical
Dictionary for Regulatory Activities (MedDRA) or on an
internal corporate code used to describe these events. The
medical reviewer also determines whether the language
describing the event is correct.
This is the point of initial triage.
If the event is judged as clearly not drug related, then the
report is completed at this point. However, if it is not clear or
is a SAE, then the event is escalated to the next level.
Depending upon the preliminary assessment of severity, the
case can be expedited. If so, information on this case is
provided to FDA for “each adverse drug experience that is
both serious and unexpected as soon as possible.” 25

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