The newsletter of the Memory Disorders Project at Rutgers University

"Regulatory Quality" Study

Before a product can be marketed as a drug in the US, it must receive approval from the Food and Drug Administration (FDA). FDA approval is granted only after a drug has undergone stringent clinical testing for effectiveness and safety, and the kind of studies which are most likely to lead to FDA approval are sometimes called "Regulatory-quality" studies.

Typically, such studies are:

In which the drug is shown to have a significant and reliable effect on treating, preventing or curing a disease or other medical or psychiatric condition.

by Catherine E. Myers. Copyright © 2006 Memory Loss and the Brain