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