New Drug Approval Process, Fifth Edition

The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.Updated chapters include:advances in international regulatory requirements, including ICH guidelines and harmonization a step-by-step format for content, assembly, and strategic approach in filing US and global INDs, NDAs, BLAs, ANDAs, and SNDAs the latest regulatory requirements for expediting new drug approvals strategies for effective communication and integration of pharmaceutical personnel in all aspects of new drug development

Richard A. Guarino is President, Oxford Pharmaceutical Resources, Inc., Totowa, New Jersey, USA. Dr. Guarino has 25 years of experience in new drug applications, marketing launches, advertising, and FDA liaison. He is former President and CEO of Oxford Research International Corp.; former Director of Clinical Research at Sandoz Pharmaceutical Inc. (now Novartis); and former Vice President/Medical Director at Revlon Healthcare Group. Dr. Guarino is a member of many professional societies and associations including the Royal Society of Medicine, the Association of Clinical Research Professionals, and the Academy of Pharmaceutical Physicians and Investigators, among others.