FDA Unveils First AI Guidance for Drug Development

On January 5, 2025, the FDA released its inaugural draft guidance for using AI in drug and biological product development, aiming to boost AI model credibility in regulatory submissions. The 90-day public feedback window invites industry input as AI-driven submissions surge. Key focuses include model trustworthiness, ethical standards, and lifecycle management. Meanwhile, concerns rise over pharmaceuticals contributing to toxic 'forever chemicals' in wastewater. As regulations tighten, pharma navigates innovation with environmental mindfulness.