Clinical Impact of Adverse Event Reporting

TABLE 3: Adverse Event (AE) Reporting Requirements for Pharmaceuticals^(22,23)

15-day "Alert Reports":

Each AE, both serious and unexpected (i.e., not in the product's current labeling), must be reported to the FDA within 15 working days

Periodic AE Reports:

All non-15 day AE reports must be reported periodically (quarterly for the first three years after approval, then annually)

Other:

The frequency of reports of 1) AEs that are both serious and expected, and 2) therapeutic failures must be periodically monitored, and any significant increase must be reported within 15 days

Scientific Literature:

A 15-day report based on scientific literature (case reports; results from a formal clinical trial; epidemiology-based studies or "analyses of experience in a monitored series of patients")

Postmarketing Studies:

No requirement for a 15-day report on an AE acquired from a postmarketing study unless manufacturer concludes pharmaceutical causation for AE "reasonable possibility"

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