Adverse Event Reports
View All Adverse Event Reports Draft Proposals
Draft Proposal 1
FDA should expand the areas in which it provides the public with online access to public information from adverse event reports about FDA-regulated products submitted to FDA, in a format that is searchable and allows users to generate summary reports of this information, including, if known and as applicable, the trade name and/or established name of the product, dosage, route of administration, description of the adverse event, and the health outcome. Adverse event report information should continue to be disclosed with a clear disclaimer about the limits of the information.