An Overview of FDA Regulated Products: From Drugs and Cosmetics to Food and Tobacco - Paperback

by Eunjoo Pacifici (Editor), Susan Bain (Editor)

Today's challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful.

Author Biography

Dr. Pacifici is currently the primary course instructor and contributing faculty in a number of regulatory science subjects within The International Center for Regulatory Science (ICRS) at University of Southern California, working to provide the next generation of regulatory scientists with the knowledge, tools, and skills to expedite the development of innovative, safe, and effective biomedical products. She is deeply involved in guiding regulatory science doctoral students in their thesis projects exploring timely and probing policy and process questions in the area of developing and delivering safe and effective products to the patients. Her professional experience reaches beyond academia to include the biopharmaceutical industry where she worked in global product development and was involved in managing clinical studies and investigational sites, developing protocols and case report forms, training site personnel, and coordinating CRO and central laboratory activities. She has also led international product development teams in a cross-functional matrix organization with members from different functional areas located at sites across the globe collaborating to study investigational medical products. Recently, she was a member of a research team exploring the possibility of repurposing an approved drug for an alternative indication. Currently, she is leading the Regulatory Knowledge and Support function of Southern California Clinical and Translational Science Institute that is working to provide regulatory training, guidance and support, furthered by research into new approaches related to conducting clinical trials in diverse communities.