Adverse Drug Experience

Adverse Drug Experience. Shall have the meaning given in 21 C.F.R. § 314.80(a).

Adverse Drug Experience. An adverse event associated with the use of Generic Product in humans, whether or not considered drug related, including the following:an adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of expected pharmacological action. The above definition of Adverse Drug... Experience is defined by 21 C. F. R. § 314. 80(a), and will be deemed to be changed to reflect any changes to that section of 21 C. F. R. § 314 View More