For 20 years, our flagship publication, Fundamentals of US Regulatory Affairs, has been giving regulatory professionals the insights and answers they need, right at their fingertips. Introducing the 10th edition of Fundamentals of US Regulatory Affairs, the cornerstone of a good regulatory library.
Navigate the complexities of the requirements and guidance’s of healthcare product regulation in one comprehensive resource. What’s new in the book:
- More than 50 subject matter experts contributed to provide updates through May 2017
- More detail on topics like preclinical trials and Good Laboratory Practices, and clinical trials and Good Clinical Practices, breaking these subjects down by product lines
- New chapters on traceability and supply chain, and biosimilars
- Easy to use matrix of applicable laws and regulations by product and lifecycle stage, plus a useful glossary and detailed index
- Convenient, fully searchable e-book available on updated e-book reader