Question

An accidental poisoning or death must be reported Within________

a) immediately
b) 24 hours
c) 36 hours
d) only deaths are reported

Answer 1

Unexpected serious and fatal adverse drug events must be reported to the FDA within 15 days by the drug sponsor, while other events are reported quarterly.

Step-by-step explanation:

An accidental poisoning or death must be reported to the relevant regulatory agency, such as the FDA, promptly when it is related to adverse drug experiences following new drug approval (NDA). For the drug sponsor, unexpected serious and fatal adverse drug events should be reported within 15 days. Meanwhile, other non-serious events can be reported on a quarterly basis. Moreover, the FDA's MedWatch program allows consumers and health professionals to voluntarily report adverse drug events, commonly referred to as "spontaneous reports".