This session will delve into the intricate landscape of the US legal and regulatory framework governing the use of artificial intelligence (AI) in pharmaceutical product development. As AI continues to revolutionize healthcare, understanding the regulatory environment is crucial for innovators and stakeholders. Speakers will explore the current regulations, guidelines, and policies set forth by US agencies such as the FDA and discuss the challenges these pose to AI integration in pharmaceutical products. Key topics to be discussed include compliance requirements for the use of RWD in drug development and the ethical implications of AI in healthcare as well as case studies of successful AI applications in pharma product development, highlighting both the hurdles overcome and the opportunities seized. By addressing these elements, the session aims to provide a comprehensive overview of the US regulatory landscape and offer strategic insights for navigating it effectively.