Thursday April 28, 2022 at 11am ET | 10am CT | 8am PT In this new video series, Drug Digest, the Pharmaceutical Technology editors examine the topic of emerging therapies in more detail, covering subjects such as the challenges of scale, the potential benefits of drug delivery innovation, importance of early analytical studies, the evolution of the regulatory landscape, and differences between regional regulatory requirements. Join the editors as they speak with experts from Regulatory Compliance Associates (RCA), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), and others.
This excerpted chapter of a longer book reviews the history of the Food, Drug, and Cosmetics act, including milestones, subsequent laws, and predictions for future laws and regulations; explores the role of Regulatory Affairs in product development; and addresses the importance of a quality management system and organization in bringing products to market.