- Overview of FDA and Drug Development
- What is an IND?
- The New Drug Application
- Meeting with the FDA
- FDA Medical Device Regulation
- The Development of Orphan Drugs
- CMC Sections of Regulatory Filings and CMC Regulatory Compliance During Investigational and Postapproval Stages
- Overview of the GxPs for the Regulatory Professional
- FDA Regulation of the Advertising and Promotion of Prescription Drugs, Biologics, and Medical Devices
- Electronic Submissions - A Guide for Electronic Regulatory Submissions to FDA The Practice of Regulatory Affairs
- A Primer of Drug/Device Law: What's the Law and How Do I Find It?
- FDA Advisory Committees
- Biologics
"an insightful distillation of the most salient and pertinent aspects of the very broad field of FDA regulation [...] an invaluable resource that should be consulted and available to those who face the ever-evolving challenges encountered in t he field of new medical product development.”
Journal of Medical Device Regulation (for the first edition)
Journal of Medical Device Regulation (for the first edition)
