Final answer:
The pharmaceutical sponsor must report unexpected serious and fatal adverse drug events within 15 days and other events quarterly to the FDA after NDA approval. Adverse drug event reporting helps in monitoring drug safety post-approval. Voluntary reports from consumers and health professionals are also vital and are known as spontaneous reports.
Step-by-step explanation:
After New Drug Application (NDA) approval, a pharmaceutical sponsor is responsible for reporting any known adverse drug experiences to the FDA. They are required to report unexpected serious and fatal adverse drug events within a 15-day window, as well as other types of events on a quarterly basis. These reports play a critical role in the continued monitoring of drug safety after initial approval and are essential for the FDA's post-marketing surveillance efforts.
Adverse drug event reports can also be submitted voluntarily by consumers and health professionals through the FDA's MedWatch program. These voluntary submissions are referred to as spontaneous reports. The process of reporting ensures the continuous assessment of a drug's safety profile, and allows for timely interventions should new risks be identified.