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For nanomedicine, these agencies require comprehensive evaluations of safety, quality, and efficacy, including preclinical studies, pharmacokinetic analyses, and large-scale clinical trials

CMSP RL, Yothers G, Jacobs SA, Sanoff HK, Cohen DJ, Guthrie KA, Henry NL, Ganz PA, Kopetz S , Lucas PC, Blanke CD, Wolmark N, Hochster HS, George TJ, Overman MJ