Overview of the FDA Drug Approval Process
The Carlat Psychiatry Report, Volume 12, Number 7&8, July 2014
Glen Spielmans, PhD
Associate professor of psychology, Metropolitan State University, St. Paul, MN
Glen Spielmans, PhD, has disclosed that he has no relevant financial or other interests in any commercial companies ertaining to this educational activity.
After a psychiatric drug is approved by the Food and Drug Administration (FDA), a marketing juggernaut often follows, trying to convince us that the newly approved drug offers substantial benefits for treating a mental disorder. But how does the FDA determine whether to approve a drug? What follows is a breakdown of the process.