[U.S. Food and Drug  Administration]

Guideline for Adverse Experience Reporting for Licensed Biological Products

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Definitions

Adverse experience
any undesirable event reported to or known by the licensed manufacturer that is associated with the use of the product in humans, whether or not considered product-related by the licensed manufacturer. Reporting an adverse experience does not necessarily reflect a conclusion by the licensed manufacturer or FDA that the event is causally related to the product. An adverse experience may occur in professional practice, as a result of self-medication, from overdose, whether accidental or intentional, from withdrawal, or when a product fails to produce the expected pharmacological action (failure of effect).

Affiliate
Any corporate entity related to the licensed manufacturer, including all subsidiaries, licensors, etc.

Causality assessment
Determination of whether there is reasonable possibility that the product is etiologically related to the adverse event. Causality assessment includes, for example, assessment of temporal relationships, dechallenge/ rechallenge information, association with (or lack of association with) underlying disease, presence (or absence) of a more likely cause, plausibility, etc.

Challenge
administration of a suspect product by any route.

Dechallenge
withdrawal of a product from the patient's therapeutic regimen.

Negative dechallenge
continued presence of an adverse experience after withdrawal of the drug.

Positive dechallenge
partial or complete disappearance of an adverse event after withdrawal of the product.

Rechallenge
reintroduction of a product suspected of having caused an adverse event following a positive dechallenge.

Negative rechallenge
failure of the product, when reintroduced, to produce signs or symptoms similar to those observed when the product was previously introduced.

Positive rechallenge
reoccurrence of similar signs and symptoms upon reintroduction of product.

CIOMS form
An adverse reaction reporting form developed by the Council for International Organizations of Medical Sciences (CIOMS), intended for notifying the regulatory authorities of countries other than the country where the report originated.

Expected experience
an adverse experience described in the ADVERSE REACTIONS, WARNINGS or PRECAUTIONS section of the current labeling. Also referred to as a labeled experience.

ICD-9-CM
The International Classification of Diseases, ninth revision, Clinical Modification. This coding system, in the context of this Guideline, is used to assign standardized numerical coding and nomenclature for underlying medical conditions and indications.

Increased frequency
an increase in the reported rate of occurrence of a particular adverse biological product experience after appropriate adjustment for biological product exposure.

IND
an investigational new drug application for a new biological product that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes.

Licensed manufacturer
An establishment issued a product license under 21 CFR 601.20.

Serious
an adverse experience that is fatal or life-threatening, is permanently disabling, requires inpatient hospitalization, or is a congenital anomaly, cancer or overdose.

Sponsor
a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization.

Study
A postmarketing, clinical or surveillance investigation with a protocol identifying specific objectives and a scientific methodology for collecting and analyzing adverse experience data. Adverse events incidental to other types of studies should be treated as spontaneous reports.

Subject
a human who participates in an investigation, either as a recipient of the investigational new drug or as a control. A subject may be a healthy human or a patient with a disease.

Suspect
a product associated with the adverse experience as determined by the initial reporter, regardless of the opinion of the licensed manufacturer.

Unexpected Experience
an adverse experience that is not listed in the current labeling for the product; this includes an event that may be symptomatically and pathophysiologically related to an event listed in the labeling, but differs from the event because of greater severity or specificity. In some cases, it may be difficult to decide whether the reported experience is expected. In these situations, the event should be considered unexpected. An unexpected experience is also referred to as an unlabeled experience.

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