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"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 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.
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