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16 If a product is more than minimally manipulated, it does not qualify as an HCTP, and is instead subject to premarket review and approval as a drug or biologic under a biologics license application (BLA)

doi: 10.1016/j.cmet.2010.05.001 113 KappelerL.De Magalhaes FilhoC.DupontJ.LeneuveP.CerveraP.PrinL.et al

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Intestinal bacterial overgrowth in the early stage of severe acute pancreatitis is associated with acute respiratory distress syndrome
