Final answer:
Reporting of delays in the commencement of community pharmacy operations is not specified under adverse drug event guidelines. The requirement after NDA approval is for sponsors to report serious and fatal adverse drug events to the FDA within 15 days, and other events quarterly. The FDA also accepts voluntary reports through the MedWatch program.
Step-by-step explanation:
In relation to the commencement of operations in a community pharmacy, regulations concerning the reporting of delays are not explicitly specified under the guidelines for adverse drug event reporting. However, the reporting of adverse drug events (ADEs) is well-defined. After New Drug Application (NDA) approval, the sponsor is required to report every patient adverse drug experience learned of to the Food and Drug Administration (FDA).
Critical events, such as unexpected serious and fatal adverse drug events, must be reported within 15 days. Other non-critical adverse drug events are to be reported on a quarterly basis. The FDA also receives voluntary adverse drug event reports through its MedWatch program, which is a platform for consumers and health professionals to submit spontaneous reports of adverse drug events.