FDA requires manufacturers, packers, and distributors of marketed prescription drug products to establish and maintain records and make reports to FDA of all serious, unexpected adverse drug experiences associated with the use of their drug products. Pharma companies must also develop written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences to FDA.
FDA law requires pharmaceutical companies to periodically report any adevrse events it has knowledge of. Before considering any clinical incident for submission to the FDA in an expedited or periodic safety report, applicants, manufacturers, and licensed manufacturers should have knowledge of the following four dats elements:
- An identifiable patient;
- And identifiable reporter;
- A suspect drug, biological product, or device; and
- An adverse event or fatal outcome.
According to the FDA, "Reporting of adverse events from the point of care is voluntary in the United States. FDA receives some adverse event and medication error reports directly from health care professionals (such as physicians, pharmacists, nurses and others) and consumers (such as patients, family members, lawyers and others). Healthcare professionals and consumers may also report these events to the products’ manufacturers. If a manufacturer receives an adverse event report, it is required to send the report to FDA as specified by regulations" (see "Adverse Event Reporting System (AERS)").
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