Hello,
One of the basic elements required to have knowledge of when reporting an adverse event is "a suspect drug or biological product". Can someone help me better understand what "a suspect drug or biologic product" term specifically refers to? In a hypothetical case, if we manufacture Advil and receive e report that a patient had an allergic reaction to ibuprofen (unknown manufacturer), are we responsible for submitting an adverse event report to FDA?
Thank you!
Eneida
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Eneida Shkurti
Norwood MA
United States
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