Guest Speaker: Stephen Weber, MD

Former-FDA Expert Consultant at NDA Partners Assistant Professor at Johns Hopkins University

The regulatory landscape for medical products is rapidly evolving as regulators and industry alike recognize the value of Real-World Evidence (RWE) and Real-World Data (RWD) in enhancing regulatory decision-making... FDA has removed key barriers for real-world evidence and emphasizes a fit-for-purpose framework focused on data quality, relevance, and methodological rigor. Updated guidances provide clearer expectations for submissions and encourage early FDA engagement. In this presentation, Dr. Weber will examine how the evolving FDA landscape is shaping RWE use across product types and highlight practical considerations for sponsors. Speaker Biography: Stephen Weber, MD is a former FDA medical reviewer with extensive experience evaluating the safety and effectiveness of medical products across the regulatory lifecycle...