Fundamentals of US Regulatory Affairs, Eighth Edition by Alix E. Alderman, Joseph C. Fratantoni, Klaus Gottlieb, Michael R. Hamrell, Donna Helms, Nigel A. S. Hernandez, Hutch Humphreys, Treena Jackson, Karen Jaffe, Jocelyn Jennings, Allison Kennedy, Patricia Anderson, William H. Kitchens, Tatiana Leshchinsky, Alan Minsk, Brian Miyazaki, Linda Pollitz, M. Prasad Palthur, Giuseppe Randazzo, Matthew Rycyk, Srikonda Sastry, Anthony P. Schiavone, Alay Bhayani, Jessica W. Smith, Michelle Sotak, Usha Srinivasan, Michael A. Swit, Mya Thomae, Anne Tomalin, Laurence M. Wallman, Maria Walsh, Diane R. Whitworth, Sherry Yanez Gregor, Clawson Bowman, Linda Yang, Andrew P. Zeltwanger, Jeffrey Zinza, Evelyn D. Cadman, Rafael Cassata, Melissa Cavuto, Ojas Chandorkar, Min Chen