AI in Medicine News ・ 💊 Drug discovery and clinical trials

AI-Generated Evidence in Drug Discovery: Reliability, Legal Risk & FDA Compliance

Crowell & Moring LLP · 10/21 17:14 UTC

The alert covers five core challenges of AI-generated evidence in life sciences: hallucinations, skewed predictions from unrepresentative training data, opaque AI reasoning, input sensitivity that undermines reproducibility, and adversarial manipulation of training data. A regulatory submission relying on AI-generated data without independent human validation may not meet existing FDA data integrity standards. AI-generated expert analysis offered in litigation may be open to challenge on reproducibility grounds under Federal Rule of Evidence 702.

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