A company receives a serious adverse event report for an off-label use of their product. Are they obligated to include it in their pharmacovigilance reporting?
-
A
No, off-label use reports are excluded from regulatory reporting
-
B
Yes, serious ADRs regardless of whether use is on- or off-label must be reported
-
C
Only if the off-label use is in a clinical trial setting
-
D
Only if the prescriber provides written consent