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9 The 505(b)(2) as a strategic weapon We often hear the pharmaceutical industry described as a binary choice: the noble quest for a new molecular entity (NME) or the low-rent race of the generic manufacturer

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During the review process, manuscripts that exhibited poor study design, lack of clearly defined eligibility criteria, irrelevant definition of exposures, contrasts, and outcomes, outdated studies, inconsequential characteristics of study participants, inadequate reporting of results, or a plurality of the study group were excluded

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