definiens: means ( a ) any finding fromtests in laboratory animals or in vitro that suggests a significant risk for human subjects including reports of mutagenicity, teratogenicity or carcinogenicity and ( b ) any undesirable, untoward or noxious event or experience associated with theclinical, commercial or other use or occurring following administration, of a product in humans, occurring at any dose, whether expected or unexpected and whether or not considered related to or caused by a product, including such an eventor experience as occurs in the course of the use of a product in professional practice, in a clinical trial, from overdose, whether accidental or intentional, from abuse, from withdrawal or from a failure of expected pharmacological or biologicaltherapeutic action of a product, and including those events or experiences that are required to be reported to the FDA under21 C.F.R. Sections 312.32 or 314.80 or to Regulatory Authorities under corresponding Applicable Law outside the UnitedStates