Reporting of adverse events

Steve Simon


This page is currently being updated from the earlier version of my website. Sorry that it is not yet fully available.

Most Institutional Review Boards (IRBs) have difficulty coping with the volume of adverse events that study sponsors report to them. The FDA held a public meeting about this issue recently, and some written responses are available as PDF files at the following location:

You can find an earlier version of this page on my original website.