Final answer:
The time required for a mandated reporter to send a written report varies, but in the context of FDA regulations, serious and fatal adverse drug experiences must be reported within 15 days.
Step-by-step explanation:
The specific timeframe a mandated reporter must send a written report after receiving information concerning an incident varies by jurisdiction and specific legal guidelines. However, the information provided mentions the practice in the context of drug safety and regulations governed by the Food and Drug Administration (FDA). After New Drug Application (NDA) approval, sponsors must review and report to the FDA any adverse drug experience they learn about.
Serious and fatal adverse drug events must be reported within 15 days, and other events are to be reported on a quarterly basis. This is part of the regulatory framework ensuring drug safety and efficacy for the public.