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The warning letter reaffirms that existing law governs AI just as any other tool : all quality-affecting documents and decisions must be reviewed and approved by competent humans in the Quality Unit (21 CFR 211.22), and statutory requirements (like process validation) cannot be bypassed by blaming an AI system ( [2] ) ( [3] )
Focus on what you drink as well: One animal study indicates that being on GLP-1 drugs may inhibit fluid intake and may increase the risk of dehydration so focusing on adequate hydration through water, teas, and even high-hydration foods (think citrus and watermelon) will be essential
The NEC Baby Formula MDL saw a modest increase in filings between March and April 2025
10.1038/sj.mp.4000805 15
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