Before a new drug can be introduced into commerce, its developers must submit scientific evidence of its safety and efficacy for treating or preventing specific diseases or medical conditions (indications) when used at precisely defined dosage levels and intervals (treatment regimen) and in stipulated formulations. Scientific evidence, to be adequate, must include results of well-controlled clinical trials by qualified experts. Since trials involve administration of experimental products to volunteer patients, investigating companies must first obtain government authorization to commence testing in humans. Thus, at minimum, two regulatory hurdles guard the pathway to the medical marketplace in most countries.
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