• Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations
• Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference
• Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations
• Eunjoo Pacifici, Associate Director, Graduate Programs, International Center for Regulatory Science, Assistant Professor of Clinical Pharmacy, Los Angeles, CA, USA.
• Susan Bain, Professor of Practice, Clinical, Regulatory and Quality, Program Director, MBS in Clinical and Regulatory Affairs, Keck Graduate Institute, School of Applied Life Sciences, School of Pharmacy, Claremont, CA, USA