Recent Advances in Regulatory Science for Pharmaceutical Development and Approval

Abstract

Ali Rahmani and Maedeh Dahaghin

Regulatory science is a vital component of pharmaceutical development and approval processes, ensuring the safety, efficacy, and quality of drugs. This article provides an overview of the background and importance of regulatory science in the pharmaceutical industry. It highlights the critical role regulatory science plays in supporting innovation and creating a predictable and transparent regulatory environment. Recent advances in regulatory science are discussed, including the use of real-world evidence, innovative trial designs, and advancements in gene and cell therapies. These developments have the potential to revolutionize drug development and approval, offering new treatment options and improving patient outcomes. However, they also introduce challenges that need to be addressed, such as ensuring the reliability of real-world evidence and adapting to the complex landscape of gene and cell therapies. Understanding the evolving field of regulatory science is crucial for pharmaceutical professionals to navigate the regulatory landscape and bring safe and effective therapies to patients.

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