Abstract

The landscape of drug development is increasingly complex, with regulatory strategies playing a critical role in bringing new therapies to market efficiently and safely. Recent research has highlighted evolving best practices in regulatory affairs, focusing on streamlining approval processes, enhancing collaboration between stakeholders, and leveraging advanced technologies to improve drug development. This article explores recent advancements in regulatory strategies, including adaptive trial designs, real-world evidence, and the integration of artificial intelligence (AI) and data analytics. It also addresses the challenges and future directions in regulatory affairs, offering insights into how best practices can be implemented to optimize the drug development process.