chapter 1. Overview of FDA and drug development / Josephine C. Babiarz and Douglas Pisano -- chapter 2. What is an IND? / Michael R. Hamrell -- chapter 3. The new drug application / Charles Monahan and Josephine C. Babiarz -- chapter 4. Meetings with the FDA / Alberto Grignolo and Sally Choe -- chapter 5. FDA medical device regulation / Barry Sall -- chapter 6. A primer of drug/device law : what is the law and how do I find it? / Josephine C. Babiarz -- chapter 7. The development of orphan drugs / Scott N. Freeman -- chapter 8. CMC sections of regulatory filings and CMC regulatory compliance during investigational and postapproval stages / Prabu Nambiar, Steven R. Koepke, and Kevin Swiss -- chapter 9. Overview of the GxPs for the regulatory professional / Bob Buckley, Robert Blanks, Kimberly J. White, and Tonya White-Salters -- chapter 10. FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Karen L. Drake -- chapter 11. The practice of regulatory affairs / David S. Mantus -- chapter 12. FDA advisory committees / Christina A. McCarthy and David S. Mantus -- chapter 13. Biologics / Florence Kaltovich -- chapter 14. Regulation of combination products in the United States / John Barlow Weiner.