Question

A written incident report must be submitted to the department within ____ days of the event. Unless it is a serious physical injury, in which case the written report shall be submitted within ___ hours

Answer 1

Adverse drug experiences must be reported to the FDA with serious and unexpected events within 15 days, and others on a quarterly basis; the FDA's MedWatch allows for voluntary spontaneous reports.

Step-by-step explanation:

The question concerns procedures for submitting incident reports, particularly in the context of adverse drug events. When it comes to the pharmaceutical industry and incident reporting to the Food and Drug Administration (FDA), there are strict timelines that must be followed. After receiving New Drug Application (NDA) approval, a sponsor is required to report any patient adverse drug experience to the FDA. Serious and fatal adverse drug events that are unexpected must be reported within 15 days, whereas other events can be reported on a quarterly basis. These guidelines ensure timely surveillance of drug safety and efficacy post-approval. Additionally, the FDA's MedWatch program allows for voluntary 'spontaneous reports' of adverse drug events from consumers and health professionals.