Final answer:
After New Drug Application (NDA) approval, crash reports for unexpected serious and fatal adverse drug events must be reported to the FDA within 15 days. Other events are reported quarterly. The FDA also gathers voluntary reports through the MedWatch program.
Step-by-step explanation:
Crash reports are required when a sponsor, after receiving NDA approval, learns about any patient adverse drug experience. Such instances necessitate prompt reporting to the FDA. When unexpected serious and fatal adverse drug events occur, they must be reported within 15 days. Other types of adverse drug experiences should be reported on a quarterly basis.
Additionally, the FDA receives spontaneous reports through its MedWatch program. Reporting through MedWatch is voluntary and can be done by consumers and health professionals. These are known as spontaneous reports because there's no mandatory requirement for these individuals to report adverse drug events; however, it contributes significantly to post-marketing surveillance of drugs.