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First major study on ‘AI psychosis’ suggests chatbots can encourage delusions among vulnerable people
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In practice, this ambiguity creates a de facto GMP floor, where companies default to the most expensive manufacturing standards simply to avoid regulatory risk. Clarifying or explicitly scaling GMP expectations for early-stage trials would allow proportionate standards. However, a key step is first modifying U.S.C. §351(a)(2)(B).
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