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Adverse Event Reports - Summary of Public Comments

View PDF of the Adverse Event Reports Section (72 KB)


Background

Transparency Report Arrow Summary of Public Comments

Considerations

View All Adverse Event Reports Draft Proposals  


Summary of Public Comments
In general, comments from individuals requested disclosure of more information about adverse events that are reported in connection with FDA-regulated products, including information about the type of event, the number of adverse events reported, and/or frequency of occurrence.  Comments noted that the information should be provided to the public in an accessible, user-friendly format, and in a timely fashion.  One comment urged the FDA to make adverse event reporting systems “straightforward to use” and to make information about adverse events “as easily retrievable as possible.”

Some comments wanted FDA to post the frequency of adverse events associated with the use of veterinary products.  Some comments noted that it would be helpful to have frequency information provided as a percentage of total adverse events reported; other comments suggested that the number of times an adverse event was reported should be disclosed.

One comment recommended that FDA harmonize and centralize its current adverse event reporting programs, stating that currently, adverse event reports are submitted to the Agency on several Web sites.

Comments that recommended the disclosure of adverse event information stated that public disclosure of adverse events associated with medical products was important to allow users of these products to make informed decisions about these products.