- Delivery: Can be download Immediately after purchasing
- Version: Only PDF Version.
- Compatible Devices: Can be read on any devices (Kindle, NOOK, Android/IOS devices, Windows, MAC)
- Quality: High Quality. No missing contents. Printable
FDA 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.