Lexology October 30, 2024
Although the rise of artificial intelligence (AI) has created many opportunities and breakthroughs for life sciences companies in preclinical and clinical development, risks associated with the use of AI cannot be ignored. Therefore, publicly traded life sciences companies that use AI are strongly encouraged to consider including detailed, company-specific risk factors in their filings with the U.S. Securities and Exchange Commission (SEC).
In October 2023, President Biden issued an Executive Order that discussed the use of AI in drug development, mandating that the Secretary of Health and Human Services develop a strategy for regulating the use of AI or AI-enabled tools in the drug development process by the end of this month (October 2024). The U.S. Food and Drug Administration...
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