Comment from ForHumanity

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Summary: ForHumanity, a non-profit organization focused on AI risk mitigation, supports the FDA's proactive approach to providing guidance on AI in drug regulatory decision-making. They argue that while the draft provides a sound foundation, it needs more specific, actionable requirements regarding bias mitigation, human intervenability, transparency, and the management of adaptive AI systems.
ForHumanity, a non-profit public charity whose mission is to examine and analyze downside risk associated with the ubiquitous advance of AI, algorithmic and autonomous systems and where possible to engage in risk mitigation to maximize the benefits of these systems… ForHumanity. Our comments are submitted on behalf of our 2200+ members from 98 countries.

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