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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 randomized,
placebo-controlled,
double-blind,
multi-site
studies, 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 |
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