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Missing IND/IDE submissions and accountability records (Clearly reflected in recent enforcement actions for unapproved SR device studies and data misrepresentation) Final Thoughts: Preventive Compliance Is the Best Strategy These Warning Letters share common themes, poor documentation, weak oversight, non-compliance with protocol or informed consent requirements, and inadequate follow-through on CAPAs

The observation that causality has not been proven has led some authors to cast doubt about the role of malnutrition as a risk factor for paracetamol toxicity

Digestion (2011) 84:1221

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& Janovsky, C

The Journal of nutrition , 155 (11), 38093822