121 STAT. 928
PUBLIC LAW 110–85—SEPT. 27, 2007
dkrause on GSDDPC44 with PUBLAW
information) since the drug was approved, since the risk evaluation and mitigation strategy was required, or since the last assessment of the approved risk evaluation and mitigation strategy for the drug; or ‘‘(B) the effectiveness of the approved risk evaluation and mitigation strategy for the drug obtained since the last assessment of such strategy. ‘‘(4) SERIOUS ADVERSE DRUG EXPERIENCE.—The term ‘serious adverse drug experience’ is an adverse drug experience that— ‘‘(A) results in— ‘‘(i) death; ‘‘(ii) an adverse drug experience that places the patient at immediate risk of death from the adverse drug experience as it occurred (not including an adverse drug experience that might have caused death had it occurred in a more severe form); ‘‘(iii) inpatient hospitalization or prolongation of existing hospitalization; ‘‘(iv) a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; or ‘‘(v) a congenital anomaly or birth defect; or ‘‘(B) based on appropriate medical judgment, may jeopardize the patient and may require a medical or surgical intervention to prevent an outcome described under subparagraph (A). ‘‘(5) SERIOUS RISK.—The term ‘serious risk’ means a risk of a serious adverse drug experience. ‘‘(6) SIGNAL OF A SERIOUS RISK.—The term ‘signal of a serious risk’ means information related to a serious adverse drug experience associated with use of a drug and derived from— ‘‘(A) a clinical trial; ‘‘(B) adverse event reports; ‘‘(C) a postapproval study, including a study under section 505(o)(3); ‘‘(D) peer-reviewed biomedical literature; ‘‘(E) data derived from the postmarket risk identification and analysis system under section 505(k)(4); or ‘‘(F) other scientific data deemed appropriate by the Secretary. ‘‘(7) RESPONSIBLE PERSON.—The term ‘responsible person’ means the person submitting a covered application or the holder of the approved such application. ‘‘(8) UNEXPECTED SERIOUS RISK.—The term ‘unexpected serious risk’ means a serious adverse drug experience that is not listed in the labeling of a drug, or that may be symptomatically and pathophysiologically related to an adverse drug experience identified in the labeling, but differs from such adverse drug experience because of greater severity, specificity, or prevalence. ‘‘(c) CONTENTS.—A proposed risk evaluation and mitigation strategy under subsection (a) shall— ‘‘(1) include the timetable required under subsection (d); and
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