Regulatory Challenges: How AI-Based Pharmacy Tools Are Shaping FDA and Global Drug Approval Pathways
Artificial intelligence (AI) is rapidly transforming the pharmaceutical landscape, revolutionizing everything from drug discovery to patient care. As AI-based pharmacy tools gain momentum, they are fundamentally reshaping regulatory frameworks, particularly those of the FDA and global drug approval bodies. This blog explores the definition, types, advantages, disadvantages, brands, real-world examples, costs, regulatory challenges, and future opportunities of AI in pharmacy, with a focus on its profound impact on drug approval pathways. What Is AI-Based Pharmacy Tools? Definition: AI-based pharmacy tools are software and hardware solutions that leverage artificial intelligence—including machine learning, natural language processing, and advanced analytics—to automate, optimize, and enhance various pharmaceutical processes. These tools can be used in drug discovery, clinical trials, medication management, regulatory compliance, supply chain optimization, and patient engagement [1] ...