Possible, but no later than 15 calendar 2026

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The ALERT initiative is intended to raise awareness of state and local government agency and industry representatives regarding food defense issues and preparedness. The initiative applies to all aspects of the farm-to-table supply chain.
Any adverse drug experience occurring at any dose 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 docHub disability/ incapacity, or a congenital anomaly/birth defect.
Reporting period SUSARs Fatal or life-threatening SUSARs as soon as possible but no later than 7 days after the sponsor become aware of the reaction. Non-fatal or non-life threatening SUSARs as soon as possible but no later than 15 days after the sponsor become aware of the reaction.

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The minimum dataset required to consider information as a reportable AE is indeed minimal, namely (1) an identifiable patient, (2) an identifiable reporter, (3) product exposure, and (4) an event.
The FDA has long had a rule (21 CFR 312.32) calling for prompt (within 15 days) reporting of any serious unexpected (i.e., not in the investigators brochure or labeling) adverse experience associated with use of a drug (i.e., if there was a reasonable possibility that the drug may have caused the event).
Summary. ALERT is a food defense program created by the FDA to decrease the risk of the deliberate contamination of food. The acronym ALERT stands for assure, look, employees, reports, and threat.

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