Here’s my CMC lecture for the 2023 University of Washington Biomedical Regulatory Affairs Masters Degree graduating class. In it, she explains how companies that produce drugs, biologics, and medical devices develop, validate, and operate processes that ensure the safety, efficacy, and quality of their products.
NSF Research Funding to Build the American Bioeconomy – is it for you?
Executive Order 14081: Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy [1] in September 2022 marked a change in thinking about the U.S. bioeconomy. The order summarizes the situation perfectly: “The...