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vitamin-b12/ PedMed
Support for Hydration and General Wellness Many patients choose IV nutrient therapy as part of a wellness plan designed to support hydration and overall well-being
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The first two claims arent supported by published human trials
FDA staff's own briefing document, posted publicly ahead of the meeting as part of the docket, proposes that TB-500 (free base) and TB-500 acetate not be added to the list, citing incomplete physicochemical characterization, a lack of evidence of effectiveness for wound healing (including an in-vitro fibroblast study in which TB-500 reportedly did not induce wound healing), and insufficient nonclinical and clinical safety data
The diaphragmatic defect measured 8.0 cm by 5.0 cm
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