Industry Terms Glossary

A

Active Ingredient

Any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.

Adverse Event (AE)

Any untoward medical event associated with the use of a drug in humans, whether or not considered drug-related.

Adverse Reaction

An undesirable effect, reasonably associated with the use of a drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. This definition does not include all adverse events observed during use of a drug, only those for which there is some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event.

Authorized Distributor of Record

A distributor with whom a manufacturer has established an ongoing relationship to distribute such manufacturer's products.