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Prioritized studies include those which have original data ( in vitro , in vivo , and human studies), described and characterized honey or its active compounds using established analytical methods (HPLC-MS and/or H-NMR spectroscopy), and have focused on mechanistic pathways related to hallmark traits of cancer including apoptosis, proliferation, inflammation, oxidative stress, and metastasis
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One affirmative voter summarized the legal distinction: “Our duty is to apply the 503A standards, not the investigational new drug application standard.” The member emphasized that inclusion would not approve a drug or indication
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