[Solved]: The FDA Adverse Event Reporting System is a…

The FDA Adverse Event Reporting System is a voluntary adverse event reporting system that – allows regulators to observe potential new safety signals of a drug if the FDA collects more than expected voluntary reports. – collects the totality of experience with drugs in the first few years after FDA approval. – relies on the fact that most US physicians and patients frequently report drug side effects they observe to FDA. – serves as a portal for patients to volunteer for randomized controlled trials being designed to address safety signals.