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What are the 4 criteria for adverse event reporting?

Information about the person who had the adverse reaction (such as age and gender); A description of the adverse reaction; The dose and name of the medicinal product suspected of causing the adverse reaction; The batch number of the medicinal product (indicated on the package);

How do I report an adverse event?

.fda.gov/Safety/MedWatch or call 1-800-FDA-1088.

What are the four main details required to report an adverse event?

Initial reporting: Any suspected adverse events or any adverse events that are considered serious and unexpected must be reported to the FDA as soon as possible but no later than within 15 calendar days of first being notified of the event.

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