This comprehensive Article explores the evolving role of artificial intelligence (AI) in the drug validation process within the U.S. Food and Drug Administration (FDA). By examining historical practices alongside emerging trends, the study assesses the legal implications and challenges associated with the integration of AI technology in pharmaceutical regulation. The exploration commences with an overview of traditional FDA validation techniques which provides a strong foundation for understanding the pre-AI regulatory framework. Through extensive analysis of case studies and empirical evidence, the Article establishes how AI enhances efficiency, accuracy, and decision-making processes in drug validation. Furthermore, the legal aspects section scrutinizes key issues encompassing transparency, cybersecurity, data protection, intellectual property rights, and regulatory decision-making, with particular emphasis on the principle of nondelegation. In addition to examining FDA advisories on AI implementation, the study suggests enhancements to optimize the application of AI within the existing regulatory framework. The conclusion emphasizes the significance of proactive measures in refining current legal structures and establishing comprehensive industry guidelines that effectively address the transformative potential of AI in drug validation. By elucidating the benefits and challenges of AI adoption, this research contributes to the ongoing discourse surrounding the appropriate utilization and regulation of AI in the field of drug validation.
