1. Overview of FDA and drug development / Josephine C. Babiarz and Douglas J. Pisano -- 2. What is an IND / Michael R. Hamrell -- 3. The new drug application / Charles Monahan and Josephine C. Babiarz -- 4. Meeting with the FDA / Alberto Grignolo -- 5. FDA medical device regulation / Barry Sall -- 6. The development of orphan drugs / Tan T. Nguyen -- 7. CMC sections of regulatory filings and CMC regulatory compliance during investigational and postapproval states / Prabu Nambiar and Steven R. Koepke -- 8. Overview of the GxPs for the regulatory professional / Bob Buckley and Robert Blanks -- 9. FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Karen L. Drake -- 10. Electronic submissions : a guide for electronic regulatory submissions to FDA / Shylendra Kumar, Yolanda Hall, and Vahe Ghahraman -- 11. The practice of regulatory affairs / David S. Mantus -- 12. A primer of drug/device law : what's the law and how do I find it? / Josephine C. Babiarz -- 13. FDA advisory committees / Christina A. McCarthy and David S. Mantus -- 14. Biologics / Timothy A. Keutzer.