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For its part, FDA proposed a pilot program where qualified external institutions can collaborate with sponsors to develop and review protocols for first-in-human (FIH) clinical trials intended for investigational new drug (IND) submissions, and several associated draft guidances, including one clarifying when developers can rely on one rigorous, adequate, and well-controlled clinical trial, along with confirmatory evidence, to support drug approvals

Rather, it reflects the evidence available, how the compound is manufactured and distributed, and whether regulators believe it should be available through established medical channels

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chronic liver disease and hepatitis may present with elevated levels Renal impairment : Reduced clearance can contribute to accumulation, though this is rarely clinically significant Solid tumours : Certain malignancies, particularly hepatocellular carcinoma and metastatic disease, may elevate B12 levels [3] Evidence suggests that unexplained markedly elevated B12 levels without supplementation may sometimes be associated with underlying disease

doi: 10.1016/j.cell.2017.12.030 97 HardimanO.Al-ChalabiA.ChioA.CorrE