Biologics: Targets and Therapy

Regulatory (FDA) Critical Clinical Initiative in Drug Research and Development

In recent years, the United States Food and Drug Administration (FDA) has kicked off a number of critical clinical initiatives to assist the sponsors in pharmaceutical research and development. These critical clinical initiatives include, but are not limited to, biosimilar drug development, cancer research, adaptive trial design, real-world data and real-world evidence, model-informed drug development, AI for mobile individualized medicine, rare disease drug development, biomarker development, precision and personalized medicine, and benefit-risk assessment. The purpose of these critical clinical initiatives is not only to provide regulatory flexibilities in drug development, but also to improve, shorten or speed up the review and approval process of drug development.