definiens: means ( i ) information on any serious unexpected adverse event related to or potentially related to the Product if the relationship of the serious adverse event to the Product is unknown, for any indication, ( ii ) any complaint related to the Product if the relationship of the complaint to the Product is unknown, for any indication, ( iii ) any information, regardless of source, sufficient to warrant the consideration of Product < Page > administration changes or ( iv ) information from in vitro or animal studies suggesting a significant hazard to humans . The phrase includes without limitation information relating to any experience or event that ( a ) suggests a significant hazard, contraindication, side effect or precaution, ( b ) is fatal or life threatening, ( c ) is permanently disabling, ( d ) requires or prolongs hospitalization, ( e ) involves a congenital anomaly, cancer or overdose, ( f ) is one not identified in nature, specificity, severity or frequency in the current investigator brochure or the approved product labeling for such product, ( g ) includes findings from tests in laboratory animals that suggest a /significant safety risk to humans, including without limitation reports of mutagenicity, teratogenicity or carcinogenicity, or ( f ) is otherwise implicated or described by any applicable United States regulations ( 21 CFR 312, 314, 600 ) and/or any foreign equivalent regulatory authority regulations