(a) Definitions. The following definitions of terms apply to this section: Adverse experience. Any adverse event associated with the use of a biological product in humans, whether or not considered product related, including the following: An adverse event occurring in the course of the use of a biological product in professional practice; an adverse event occurring from overdose of the product whether accidental or intentional; an adverse event occurring from abuse of the product; an adverse event occurring from withdrawal of the product; and any failure of expected pharmacological action.
CFR 21-600.80-2014 history
2014CFR 21-600.80-2014 Food and drugs. Part600:Biological products:general. SubpartD:Reporting of adverse experiences. Section600.80:Postmarketing reporting of adverse experiences.