chapter 1 Overview of Drug Development and the FDA / chapter 2 Regulatory Strategy / chapter 3 What Is an IND? / chapter 4 Formatting, Assembling, and Submitting the New Drug Application (NDA) -- chapter 5 Meeting with the FDA / chapter 6 Biologics / chapter 7 FDA Medical Device Regulation / chapter 8 The Development of Orphan Drugs / chapter 9 Good Clinical Practices / chapter 10 Good Manufacturing Practices (GMPs) and Enforcement Actions -- chapter 11 Electronic Submissions: A Guide for Electronic Regulatory Submissions to the FDA -- chapter 12 The Practice of Regulatory Affairs / chapter 13 A Primer of Drug/Device Law, or What's the Law and How Do I Find It?.