This 11th edition of Fundamentals of US Regulatory Affairs presents information covering all lifecycle stages of regulated healthcare products. More than 50 authors contributed to the content, which is current through April 2019. The content in this edition is more detailed than in the past and includes a new chapter on the master protocol. The book is divided into eight sections:
I: General Information
III: Medical Devices
VI: Other Product Classifications
VII: Inspection and Enforcement
General chapters cover such topics as the history of US regulation, FDA meetings, user fees, regulatory strategy, healthcare fraud and abuse and traceability. Specific sections discuss product development through postmarket compliance. Other chapters address orphan drugs, foods, blood products and those derived from blood as well as tissue and cellular products.
Who Should Use This Publication?
Fundamentals of US Regulatory Affairs is designed for regulatory professionals working on products for the US market at all levels and is a useful tool for those planning to sit for the RAC US, drug or medical device exam. Whether you’re new to the profession or a veteran, you’ll find valuable information in the carefully curated pages.
Also available as an e-book.
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