The FDA regulations contain provisions establishing a system for reviewing reports of adverse events and submitting them to the FDA. Only certain reports must be sent to the FDA, depending on the nature of the event and the source of the information. Before 1997, there were several differences in the regulatory requirements for the reporting of adverse events between investiga-tional and marketed products. Those changes have largely disappeared as a result of a final rule designed to create consistency in pre- and postmarketing adverse event reporting and to bring the FDA requirements more in-line with international standards.

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