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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

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Furthermore, the immunofluorescence results showed a significant decrease in the number of PATS after treatment (Fig

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