By Ronald D Mann; Elizabeth B Andrews
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64(b). Depending on several criteria discussed below, FDA regulations provide two mechanisms for reporting adverse event and other safety information about investigational drugs to the Agency. Sponsors report adverse experiences to the FDA either as (1) an expedited report, or (2) as part of an IND annual report. R. 32 – 33. Adverse experiences that are not reported to the FDA under one of these two mechanisms are usually included in listings submitted to FDA as part of a final study report. Expedited Reports —Telephone and Written IND Safety Reports The goal of expedited safety reporting is to ensure timely communication to the FDA of the most important new information about the safety of investigational drugs.
A telephone IND safety report is required when an adverse event is fatal or life-threatening. A written IND safety report is required if the event is serious. Id. 32(c). FDA regulations define a serious adverse event for subjects receiving investigational drugs as one that results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability= incapacity, or a congenital anomaly=birth defect.
80(b). The regulations require applicants or licensed manufacturers to retain records of all adverse product experiences, including raw data and any related correspondence, for 10 years. R. 80(i). R. 80), there are some product-specific differences. R. 3(c)) are exempt from these requirements. Rather, these products must keep adverse reactions records and make those available to the FDA upon request. R. 170(a). With regard to a ‘‘complication of blood collection or transfusion’’ that is fatal, this information must be communicated to the FDA as soon as possible, followed by a written report within seven days.