All Times EDT
Keywords: Bayesian
Bayesian approaches have been used in the regulatory setting for trial design and medical product approval. The use of Bayesian approaches in regulatory submissions is not without challenges. In this presentation, I will provide Bayesian approaches utilized in the design and approval of biologic products regulated by FDA’s Center for Biologics Evaluation and Research (CBER) followed by examples. A discussion of regulatory perspective on the approaches, challenges and values will be provided.