Advertisements and Promotional Labeling Transmittal: FDA Form 2253

Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use (Food and Drug Administration)

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Adverse Reaction

Any noxious and unintended response(s) to a medical product or procedure, for which a causal relationship with this product or procedure is…

Adverse Event Yes No Indicator

An indication of whether an adverse event has occurred.

Adverse Event Verbatim Description

The verbatim description of the adverse event.

Adverse Event Unexpected Reason Code

A coded value specifying the representation of the criteria for determining whether an adverse event (experience or reaction) is considered unanticipated. …

Adverse Event Toxicity Grade

The toxicity grade value of the adverse event.

Adverse Event Summary

A description of the adverse event and the treatment of the event.