The Role of Investigational New Drugs Applications in Emergency Use Authorization (EUA) of New Drug Molecules

Abstract

The demand for effective and adaptable authorization processes increased as a result of the COVID-19 pandemic's extraordinary global health catastrophe, which altered regulatory frameworks for drug development. In order to guarantee the safety and scientific integrity of experimental treatments, the Investigational New Drug (IND) application has long been a vital entry point for clinical trials in the US. However, the Emergency Use Authorization (EUA) mechanism offered a supplemental regulatory tool to enable the quick deployment of potentially life-saving medical measures during public health emergencies, like the COVID-19 pandemic. The complex relationship between IND filings and EUA approvals is highlighted in this review, which also shows how early-phase IND data was crucial in facilitating EUA decisions for important medications and vaccines. In addition to discussing how these data sets were repurposed to meet EUA standards under the U.S. Food and Drug Administration (FDA) and international agencies, the paper examines the structural framework of the IND process, including preclinical data, manufacturing quality, and clinical trial protocols. Remdesivir, monoclonal antibodies, and mRNA-based vaccines are notable examples of case studies that highlight the importance of IND-backed data in bolstering EUA approvals under COVID-19. The study assesses the effects on future disaster preparedness of regulatory flexibilities used during the pandemic, including adaptive trial designs, rolling reviews, and the utilization of real-world evidence. In the context of rapid authorizations, ethical factors such as informed consent, data openness, and public trust are also investigated. By proposing the creation of a hybrid IND-EUA paradigm to expedite future responses to global health issues, these offer a forward-looking viewpoint. Stakeholders can improve the responsiveness, safety, and effectiveness of future drug approval pathways during emergencies by taking lessons from the regulatory agility seen during COVID-19.