Author Description

FDA Quality Standards for Generic Drug Products features the history and evolution of the FDA’s generic drug program, along with an overview of the quality assessment process performed by the FDA and an in-depth look at quality standards for a variety of dosage forms. Chapters cover important topics such as quality by design, the ANDA structure, CMC, process analytical technology and other emerging technologies, design of experiments and statistics and the similarities and differences between the FDA and international regulatory agencies. Edited and written by experienced leaders in the field, this book contains case studies throughout and provides insider perspectives on what the future may hold for generic drugs. An essential resource for pharmaceutical, regulatory and academic scientists, this book can be used to establish the necessary procedures and specifications in order to seek approval to develop quality products more quickly and easily. Highlights recent developments regarding quality by design and quality standards associated with particular dosage forms, including complex generic drug products Offers an overview of the FDA’s current assessment process for ANDAs, from filing to approval, and discuses important considerations regarding post-approval changes and lifecycle management Written by FDA scientists who actively review ANDAs and develop regulatory policies associated with generic drugs