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Description

Currently, chemotherapy is the first-line tool to minimize the prevalence and incidence of schistosomiasis [8,9,10]

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When FDA investigators informed the firm that process validation had not been conducted prior to product distribution (which is a foundational cGMP requirement under 21 CFR 211.100), the company responded that it had been unaware of the legal obligation because its AI agent had never flagged it as a requirement

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