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FDA guidance documents describe the Agency’s current thinking but do not independently establish legally enforceable requirements

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Galbraith Road A-125, Cincinnati, OH 45220, USA [email protected] This article was submitted to Neuroendocrine Science, a section of the journal Frontiers in Neuroscience Disclaimer All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers