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Lastly, in Section III, double-blind or cross-over studies are performed to further consider the efficacy of the drug in bigger groups of hundreds of sufferers. When Phase III is completed and if the outcomes meet the goals initially established, a brand new drug application (NDA) will be submitted to the FDA or its congener in another country. After several years of preclinical analysis, 4 to six years of clinical trials, and as many as three years after the NDA has been submitted, the FDA may then approve advertising of the drug. At that point, Phase IV is initiated and a mechanism of post-advertising surveillance, including reporting of opposed effects, might be in place.
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