Description
Book SynopsisFDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more.
The Third Edition of this highly successful publication:
- Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing
- Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL
- Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and correspond
