Overview of the FDA Drug Approval Process Carlat Reports

Overview of the FDA Drug Approval Process

The Carlat Psychiatry Report, Volume 12, Number 7&8, July 2014
https://www.thecarlatreport.com/newsletter-issue/tcprv12n7-8/

From The Carlat Psychiatry Report, July 2014, Research in Psychiatry

Issue Links: Learning Objectives | Editorial Information

Topics: Understanding Psychiatric Research

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.

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